Sildenafil's U.S. regulatory history spans multiple products, indications, dosage forms and application pathways. The timeline begins with FDA approval of Viagra for erectile dysfunction in 1998, followed by Revatio for pulmonary arterial hypertension in 2005 and later approvals involving new formulations, generic products and additional sildenafil brands.
The dates are product-specific. Sildenafil is the active drug, while Viagra, Revatio, LIQREV, VYBRIQUE and approved generic products have their own regulatory applications or abbreviated applications, labeling contexts and approval histories.
This page focuses on FDA approval records and major U.S. regulatory milestones rather than the discovery story. The research and development narrative is covered separately on the sildenafil history page.
There is no single FDA approval date that applies to every sildenafil product. The March 1998 approval established the first U.S. sildenafil product, but later brands, indications, dosage forms and generic products required their own regulatory actions.
The timeline therefore includes both original NDAs and later regulatory milestones: Viagra for ED, Revatio for PAH, additional Revatio formulations, the first generic sildenafil tablets referencing Viagra, pediatric PAH labeling and newer 505(b)(2) products such as LIQREV and VYBRIQUE.
Reading the history by product, application, indication and dosage form prevents later sildenafil approvals from being incorrectly treated as though they were all part of the original 1998 action.
| Date | Product / Milestone | Regulatory Context |
|---|---|---|
| March 27, 1998 | Viagra | Original U.S. sildenafil approval for erectile dysfunction |
| June 3, 2005 | Revatio tablets | Original Revatio approval for pulmonary arterial hypertension |
| May 22, 2009 | Revatio label expansion | PAH labeling expanded to include delay in clinical worsening |
| November 18, 2009 | Revatio injection | Separate NDA for an intravenous sildenafil dosage form |
| August 30, 2012 | Revatio oral suspension | Separate NDA for powder for oral suspension |
| March 9, 2016 | First generic sildenafil tablets referencing Viagra | FDA approval of Teva sildenafil citrate tablets 25 mg, 50 mg and 100 mg under an ANDA |
| January 31, 2023 | Revatio pediatric PAH indication | PAH indication expanded to pediatric patients 1 to 17 years old |
| April 28, 2023 | LIQREV | 505(b)(2) NDA approval of sildenafil oral suspension for adult PAH |
| December 16, 2025 | VYBRIQUE | 505(b)(2) NDA approval of sildenafil oral film for erectile dysfunction |
The foundational U.S. regulatory milestone for sildenafil occurred on March 27, 1998, when FDA approved Viagra under NDA 20-895.
The original application covered sildenafil citrate tablets in 25 mg, 50 mg and 100 mg strengths for the treatment of erectile dysfunction. This is the regulatory event behind the commonly cited statement that sildenafil received its initial U.S. approval in 1998.
The relationship between the active ingredient and brand is explained separately on the sildenafil and Viagra page.
| Regulatory Element | 1998 Viagra Approval |
|---|---|
| Brand | Viagra |
| Active drug | Sildenafil |
| Application | NDA 20-895 |
| Approval date | March 27, 1998 |
| Dosage form | Tablet |
| General indication context | Erectile dysfunction |
Modern sildenafil-containing prescribing information can state 'Initial U.S. Approval: 1998' even when the particular product was approved many years later. That statement identifies the original U.S. approval history associated with sildenafil rather than the NDA approval date of every later finished product.
For example, LIQREV was approved in 2023 and VYBRIQUE in 2025, yet their labeling can still place sildenafil within the initial 1998 U.S. approval history.
The distinction prevents two different regulatory dates from being confused: the first U.S. sildenafil approval and the approval date of the specific product or formulation being read.
| Date Concept | Meaning |
|---|---|
| Initial U.S. sildenafil approval | 1998 |
| Original Viagra approval | March 27, 1998 |
| Original Revatio approval | June 3, 2005 |
| LIQREV product approval | April 28, 2023 |
| VYBRIQUE product approval | December 16, 2025 |
| Every sildenafil product approved in 1998? | No |
FDA approved Revatio under NDA 21-845 on June 3, 2005, creating a separate branded sildenafil product for pulmonary arterial hypertension.
The original Revatio product was a 20 mg oral tablet. Its initial approved PAH indication focused on improving exercise ability in patients with WHO Group I pulmonary arterial hypertension.
The sildenafil–Revatio entity relationship is covered on the sildenafil and Revatio page.
| Regulatory Element | 2005 Revatio Approval |
|---|---|
| Brand | Revatio |
| Active drug | Sildenafil |
| Application | NDA 21-845 |
| Approval date | June 3, 2005 |
| General indication context | Pulmonary arterial hypertension |
| Original dosage form | 20 mg oral tablet |
Viagra and Revatio both contain sildenafil, but they were reviewed as different drug products under separate NDAs and for different original indication contexts.
Their approval dates therefore describe different regulatory events. The 1998 Viagra approval did not itself approve Revatio, PAH use, sildenafil injection or later oral-suspension products.
The direct product-level relationship is explored on the Viagra vs Revatio page.
| Feature | Viagra | Revatio |
|---|---|---|
| Active ingredient | Sildenafil | Sildenafil |
| Original NDA | 20-895 | 21-845 |
| Original approval year | 1998 | 2005 |
| Original indication context | Erectile dysfunction | Pulmonary arterial hypertension |
| Original dosage form | Tablet | Tablet |
On May 22, 2009, FDA approved a supplemental Revatio application that expanded the PAH indication beyond the original exercise-ability wording.
The updated labeling described treatment of pulmonary arterial hypertension to improve exercise ability and delay clinical worsening. The recommended 20 mg three-times-daily oral regimen remained unchanged in that action.
This was a supplemental regulatory action on NDA 21-845 rather than approval of a new active ingredient or new sildenafil brand.
| Element | 2009 Supplemental Action |
|---|---|
| Application context | Revatio NDA 21-845 supplement |
| Date | May 22, 2009 |
| Type of change | Indication / labeling expansion |
| Added outcome language | Delay in clinical worsening |
| New active ingredient? | No |
FDA subsequently approved Revatio injection under NDA 22-473 on November 18, 2009.
The new NDA covered an intravenous sildenafil dosage form within the PAH framework. FDA review documents described the formulation for patients receiving oral Revatio who were temporarily unable to take oral medication.
Because the route and dosage form differed from the earlier tablet product, the injection received its own NDA rather than being treated as though it had been approved automatically with the 2005 tablet. The route differences are covered on the oral vs injectable sildenafil page.
| Regulatory Element | Revatio Injection |
|---|---|
| Application | NDA 22-473 |
| Approval date | November 18, 2009 |
| Dosage form | Injection |
| Route | Intravenous |
| Product context | Pulmonary arterial hypertension |
FDA approved Revatio powder for oral suspension under NDA 203109 on August 30, 2012.
The approval created another sildenafil dosage form within the Revatio PAH product framework. FDA review records described the suspension as a liquid alternative relevant to patients unable to swallow a tablet.
The approval should be distinguished from later ready-to-use sildenafil oral-suspension products approved under their own applications. The pharmaceutical differences between solid and liquid sildenafil formulations are covered on the sildenafil tablets vs oral suspension page.
| Regulatory Element | Revatio Oral Suspension |
|---|---|
| Application | NDA 203109 |
| Approval date | August 30, 2012 |
| Dosage form | Powder for oral suspension |
| Route | Oral |
| Product context | Revatio / pulmonary arterial hypertension |
A separate regulatory milestone occurred on March 9, 2016, when FDA approved Teva's sildenafil citrate tablets in 25 mg, 50 mg and 100 mg strengths as the first generic approval referencing Viagra.
Generic approval uses an Abbreviated New Drug Application rather than a new NDA for the active ingredient. The regulatory question is pharmaceutical equivalence and bioequivalence to the applicable reference listed drug, together with the other ANDA requirements.
The approval date should also be distinguished from commercial availability. FDA notes generally that approval of a generic application does not necessarily mean the product becomes commercially available on the same day.
| Regulatory Element | 2016 Generic Milestone |
|---|---|
| Generic product | Sildenafil citrate tablets |
| Applicant | Teva Pharmaceuticals USA |
| ANDA | 077342 |
| Approval date | March 9, 2016 |
| Strengths | 25 mg, 50 mg and 100 mg |
| Reference brand | Viagra |
The 2012 Revatio regulatory history included pediatric study findings in labeling, but that action should not be confused with the later FDA approval of a pediatric PAH indication.
The 2012 pediatric labeling discussed a randomized pediatric study and longer-term follow-up, including concern about increased mortality at higher doses. At that time, chronic Revatio use in children was not recommended in the labeling.
The regulatory position changed after additional evidence and later review. A formal pediatric PAH indication was subsequently approved in 2023, so the two milestones need to remain chronologically distinct.
| Period | Regulatory Context |
|---|---|
| 2012 | Pediatric study and long-term safety information added to labeling |
| 2014 | Additional long-term pediatric safety-extension information incorporated |
| Later review | Additional evidence evaluated |
| 2023 | Pediatric PAH indication approved |
On January 31, 2023, FDA approved Revatio for pulmonary arterial hypertension in pediatric patients 1 to 17 years old.
The approved pediatric indication addresses improvement in exercise ability and, for patients too young to perform standardized exercise testing, pulmonary hemodynamics considered to underlie improvement.
This action is particularly important in the regulatory timeline because it followed the earlier pediatric safety history and demonstrates why an old Revatio label cannot be assumed to represent the current approved indication.
| Regulatory Element | 2023 Pediatric Milestone |
|---|---|
| Brand | Revatio |
| Active drug | Sildenafil |
| Approval date | January 31, 2023 |
| Population | Pediatric patients 1 to 17 years old |
| Indication context | Pulmonary arterial hypertension |
FDA approved LIQREV under NDA 214952 on April 28, 2023. LIQREV is a sildenafil oral suspension containing 10 mg/mL and was approved for pulmonary arterial hypertension in adults.
The application was submitted under section 505(b)(2), meaning LIQREV has its own NDA while relying in part on FDA's previous findings or other permissible evidence rather than representing a generic ANDA for Revatio suspension.
This distinction matters because LIQREV and Revatio oral suspension can share sildenafil and a liquid dosage-form context while remaining separate FDA-approved products with separate applications and product labeling.
| Regulatory Element | LIQREV |
|---|---|
| Brand | LIQREV |
| Application | NDA 214952 |
| Application pathway | 505(b)(2) |
| Approval date | April 28, 2023 |
| Dosage form | Oral suspension, 10 mg/mL |
| Approved population context | Adults with pulmonary arterial hypertension |
A major recent sildenafil milestone occurred on December 16, 2025, when FDA approved VYBRIQUE under NDA 210858 for the treatment of erectile dysfunction.
VYBRIQUE is a sildenafil oral film approved through the 505(b)(2) pathway. Current labeling lists 25 mg, 50 mg, 75 mg and 100 mg individually packaged oral-film strengths.
The approval adds a distinct dosage form to the U.S. erectile-dysfunction sildenafil landscape more than 27 years after the original Viagra tablet approval. It should therefore appear in a current regulatory timeline rather than treating the 1998 tablet as the only ED sildenafil product approval.
| Regulatory Element | VYBRIQUE |
|---|---|
| Brand | VYBRIQUE |
| Application | NDA 210858 |
| Application pathway | 505(b)(2) |
| Approval date | December 16, 2025 |
| Dosage form | Oral film |
| Strengths | 25 mg, 50 mg, 75 mg and 100 mg |
| Indication | Erectile dysfunction |
FDA approval attaches to specific applications and finished drug products rather than granting one unlimited approval to every future use or formulation of an active ingredient.
That is why sildenafil's regulatory history contains multiple NDAs: Viagra tablets, Revatio tablets, Revatio injection, Revatio powder for oral suspension, LIQREV oral suspension and VYBRIQUE oral film all have distinct application contexts.
Generic sildenafil products add another regulatory pathway. They are generally approved through ANDAs referencing an appropriate listed drug rather than receiving another original sildenafil NDA.
| Application | Product Context |
|---|---|
| NDA 20-895 | Viagra tablets |
| NDA 21-845 | Revatio tablets |
| NDA 22-473 | Revatio injection |
| NDA 203109 | Revatio powder for oral suspension |
| NDA 214952 | LIQREV oral suspension |
| NDA 210858 | VYBRIQUE oral film |
| ANDA 077342 | First generic sildenafil citrate tablets referencing Viagra |
An original NDA establishes approval for a specific drug product application, while a supplemental NDA requests an approved change to an existing NDA. A later formulation can also be submitted as a new NDA even when sildenafil itself is already well established.
The 2009 expansion of Revatio's PAH indication was a supplemental action on the existing tablet NDA. In contrast, Revatio injection and powder for oral suspension received separate NDAs, as did later LIQREV and VYBRIQUE products.
Generic ANDAs form another category again. The distinction between NDA, supplemental NDA and ANDA is therefore central to reading sildenafil's regulatory history accurately.
| Regulatory Term | Meaning |
|---|---|
| Original NDA | Application establishing approval for a specific drug product |
| 505(b)(2) NDA | NDA pathway that can rely partly on evidence not owned by or directly referenced by the applicant |
| Supplemental NDA | Application requesting a change to an already approved NDA |
| ANDA | Abbreviated application pathway used for an eligible generic product |
| Label revision | Regulatory update that can reflect newly approved or required information |
Sildenafil is now represented in U.S. FDA history by several pharmaceutical forms. Tablets, injection, powder for oral suspension, ready-to-use oral suspension and oral film are not one interchangeable regulatory product merely because each contains sildenafil.
Each dosage form raises formulation-specific quality, manufacturing, pharmacokinetic and administration questions. Some were added within the Revatio product family, while LIQREV and VYBRIQUE entered the market through separate 505(b)(2) NDAs.
The broader pharmaceutical landscape is explained on the sildenafil formulations page.
| Formulation | Key FDA Milestone |
|---|---|
| Viagra tablet | 1998 original sildenafil milestone |
| Revatio tablet | 2005 PAH product approval |
| Revatio injection | 2009 separate formulation NDA |
| Revatio powder for oral suspension | 2012 separate formulation NDA |
| LIQREV oral suspension | 2023 separate 505(b)(2) NDA |
| VYBRIQUE oral film | 2025 separate 505(b)(2) NDA |
An indication identifies the clinical use authorized in product labeling, while dosage form describes how the pharmaceutical product is supplied and administered. The same active drug can therefore appear in different indication and formulation combinations.
Viagra and VYBRIQUE provide two ED examples using different dosage forms, while Revatio and LIQREV illustrate separate sildenafil product histories within PAH. A regulatory action can change an indication without creating a new dosage form, or approve a new dosage form without introducing a new active ingredient.
Keeping active drug, brand, indication, formulation, route and application number separate makes the approval timeline substantially easier to interpret.
| Regulatory Layer | Examples |
|---|---|
| Active drug | Sildenafil |
| Brands | Viagra, Revatio, LIQREV, VYBRIQUE |
| Indications | Erectile dysfunction or pulmonary arterial hypertension depending on product |
| Dosage forms | Tablet, injection, powder for oral suspension, oral suspension, oral film |
| Routes | Oral or intravenous |
| Application pathways | NDA, 505(b)(2) NDA, supplemental NDA or ANDA depending on the regulatory action |
FDA approval of sildenafil in multiple products does not mean that every sildenafil brand, dosage form or strength is automatically substitutable across products and indication contexts.
Viagra, Revatio, LIQREV and VYBRIQUE all contain sildenafil, but each exists within its own approved product and labeling framework. Generic interchangeability questions require the appropriate reference product and FDA therapeutic-equivalence context rather than active-ingredient identity alone.
Product-specific labeling remains the controlling source for approved indication, formulation, strength, administration and other regulatory information.
| Shared Feature | Does It Establish Interchangeability? |
|---|---|
| Same active drug | No |
| Same PDE5 mechanism | No |
| Different NDA products | No automatic interchangeability |
| Generic referencing an appropriate listed drug | Requires the applicable FDA generic / therapeutic-equivalence framework |
| Different route or dosage form | Requires product-specific regulatory context |
Regulatory history begins with formal drug applications, FDA review and approval actions. Discovery history begins earlier with laboratory research, medicinal chemistry, clinical development and observations that ultimately led sildenafil toward erectile-dysfunction development.
The regulatory timeline also continues long after discovery. Generic approvals, new dosage forms, new products and indication changes have extended sildenafil's FDA history from 1998 through at least the 2025 approval of VYBRIQUE.
For the development story before and around the first approval, see the sildenafil history page. This page remains focused on U.S. regulatory milestones and product records.
| Page Topic | Primary Question |
|---|---|
| Sildenafil history | How was sildenafil discovered and developed? |
| Sildenafil FDA approval | When and through which regulatory applications were sildenafil products and indications approved? |
The clearest way to interpret sildenafil's FDA history is to identify the active drug first and then ask which product, application pathway, indication, dosage form and approval date are being discussed.
The March 1998 Viagra approval established the first U.S. sildenafil milestone. Revatio created a separate PAH history beginning in 2005, generic tablets added the ANDA pathway in 2016, pediatric PAH labeling changed in 2023, LIQREV added a separate adult-PAH oral suspension product in 2023 and VYBRIQUE added an ED oral-film product in 2025.
FDA approval history therefore remains dynamic after an original NDA. A statement that sildenafil was 'FDA approved in 1998' is historically correct at the active-drug level but incomplete when the question concerns a particular modern product, dosage form or approved indication.
| Question | Regulatory Answer |
|---|---|
| When was sildenafil first approved in the U.S.? | March 27, 1998 |
| Which product established that milestone? | Viagra |
| When was Revatio originally approved? | June 3, 2005 |
| When was Revatio injection approved? | November 18, 2009 |
| When was Revatio oral suspension approved? | August 30, 2012 |
| When was the first generic sildenafil tablet approval referencing Viagra? | March 9, 2016 |
| When was Revatio's pediatric PAH indication approved? | January 31, 2023 |
| When was LIQREV approved? | April 28, 2023 |
| When was VYBRIQUE approved? | December 16, 2025 |
Sildenafil's first U.S. FDA approval occurred on March 27, 1998, when FDA approved Viagra under NDA 20-895 for erectile dysfunction.
The original Revatio 20 mg tablet product was approved under NDA 21-845 on June 3, 2005 for pulmonary arterial hypertension.
FDA's first generic-drug records list Teva sildenafil citrate tablets in 25 mg, 50 mg and 100 mg strengths as approved on March 9, 2016 referencing Viagra. FDA approval and commercial availability should not be assumed to occur on the same date.
FDA approved LIQREV sildenafil oral suspension under NDA 214952 on April 28, 2023 for pulmonary arterial hypertension in adults.
FDA approved VYBRIQUE sildenafil oral film under NDA 210858 on December 16, 2025 for erectile dysfunction.
The 1998 statement refers to sildenafil's initial U.S. approval history. A later product can have its own much newer NDA approval date, such as LIQREV in 2023 or VYBRIQUE in 2025.