Active ingredient
Sildenafil
234 finished FDA listings contain Sildenafil as their only active ingredient.
At a glance
From the FDA NDC Directory
- Ingredient names as written by FDA
- SILDENAFIL, SILDENAFIL CITRATE
- Dosage forms
- Film, For Suspension, Injection, Solution, Powder, For Suspension, Tablet, Tablet, Film Coated
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 65
- Strengths listed
- .8 mg/ml · 10 mg/12.5ml · 10 mg/ml · 100 mg/1 · 20 mg/1 · 25 mg/1 · 50 mg/1 · 75 mg/1
- Brand names in FDA listings
- Revatio, Sildenafil, Sildenafil Citrate, Viagra, Vybrique
Official drug information
Source coverage for Sildenafil:
- FDA NDC Directory: linked
- RxNorm: linked
- Drugs@FDA: linked
- DailyMed: linked
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 136411
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
- Application
- NDA 020895
- Sponsor
- VIATRIS
- Original approval
- 1998-03-27
- Listings
- 9
- Application
- NDA 021845
- Sponsor
- VIATRIS
- Original approval
- 2005-06-03
- Listings
- 2
- Application
- NDA 022473
- Sponsor
- VIATRIS
- Original approval
- 2009-11-18
- Listings
- 1
- Application
- NDA 203109
- Sponsor
- VIATRIS
- Original approval
- 2012-08-30
- Listings
- 1
- Application
- ANDA 091479
- Sponsor
- TORRENT PHARMS LTD
- Original approval
- 2012-11-06
- Listings
- 9
- Application
- ANDA 202598
- Sponsor
- CHARTWELL RX
- Original approval
- 2012-11-06
- Listings
- 1
- Application
- ANDA 078380
- Sponsor
- TEVA PHARMS
- Original approval
- 2013-01-07
- Listings
- 1
- Application
- ANDA 202025
- Sponsor
- AMNEAL PHARMS
- Original approval
- 2013-02-28
- Listings
- 9
- Application
- ANDA 203814
- Sponsor
- MACLEODS PHARMS
- Original approval
- 2013-12-17
- Listings
- 12
- Application
- ANDA 203623
- Sponsor
- HETERO LABS LTD V
- Original approval
- 2014-11-26
- Listings
- 7
- Application
- ANDA 203988
- Sponsor
- EUGIA PHARMA
- Original approval
- 2015-04-01
- Listings
- 1
- Application
- ANDA 203963
- Sponsor
- AUROBINDO PHARMA LTD
- Original approval
- 2015-11-18
- Listings
- 2
- Application
- ANDA 077342
- Sponsor
- TEVA
- Original approval
- 2016-03-09
- Listings
- 6
- Application
- ANDA 204883
- Sponsor
- RUBICON RESEARCH
- Original approval
- 2016-06-20
- Listings
- 6
- Application
- ANDA 210394
- Sponsor
- AJANTA PHARMA LTD
- Original approval
- 2018-05-04
- Listings
- 9
- Application
- ANDA 204882
- Sponsor
- RUBICON RESEARCH
- Original approval
- 2018-06-11
- Listings
- 7
- Application
- ANDA 091448
- Sponsor
- TORRENT
- Original approval
- 2018-06-11
- Listings
- 12
- Application
- ANDA 203962
- Sponsor
- AUROBINDO PHARMA LTD
- Original approval
- 2018-06-11
- Listings
- 10
- Application
- ANDA 202659
- Sponsor
- HETERO LABS LTD V
- Original approval
- 2018-06-11
- Listings
- 25
- Application
- ANDA 202023
- Sponsor
- AMNEAL PHARMS NY
- Original approval
- 2018-06-27
- Listings
- 6
- Application
- ANDA 206401
- Sponsor
- AJANTA PHARMA LTD
- Original approval
- 2018-10-12
- Listings
- 18
- Application
- ANDA 211092
- Sponsor
- AMNEAL PHARMS
- Original approval
- 2019-11-27
- Listings
- 2
- Application
- ANDA 212883
- Sponsor
- AJANTA PHARMA LTD
- Original approval
- 2019-11-27
- Listings
- 1
- Application
- ANDA 207178
- Sponsor
- APPCO
- Original approval
- 2020-03-02
- Listings
- 12
- Application
- ANDA 211534
- Sponsor
- TEVA PHARMS USA
- Original approval
- 2020-05-29
- Listings
- 1
- Application
- ANDA 213032
- Sponsor
- SUNSHINE
- Original approval
- 2020-06-11
- Listings
- 3
- Application
- ANDA 208494
- Sponsor
- REYOUNG
- Original approval
- 2020-06-12
- Listings
- 6
- Application
- ANDA 209302
- Sponsor
- UMEDICA
- Original approval
- 2020-08-25
- Listings
- 19
- Application
- ANDA 213814
- Sponsor
- CHARTWELL RX
- Original approval
- 2021-04-29
- Listings
- 1
- Application
- ANDA 213014
- Sponsor
- HETERO LABS LTD V
- Original approval
- 2021-05-11
- Listings
- 1
- Application
- ANDA 214641
- Sponsor
- MSN
- Original approval
- 2022-02-08
- Listings
- 1
- Application
- ANDA 211638
- Sponsor
- LUPIN
- Original approval
- 2022-03-23
- Listings
- 1
- Application
- ANDA 215708
- Sponsor
- ZYDUS LIFESCIENCES
- Original approval
- 2022-09-29
- Listings
- 2
- Application
- ANDA 214773
- Sponsor
- AUROBINDO PHARMA LTD
- Original approval
- 2022-12-23
- Listings
- 1
- Application
- ANDA 202255
- Sponsor
- MACLEODS PHARMS
- Original approval
- 2023-04-19
- Listings
- 5
- Application
- ANDA 216383
- Sponsor
- NOVITIUM PHARMA
- Original approval
- 2023-08-29
- Listings
- 3
- Application
- ANDA 218045
- Sponsor
- CADILA PHARMS LTD
- Original approval
- 2023-11-28
- Listings
- 6
- Application
- ANDA 201156
- Sponsor
- JUBILANT GENERICS
- Original approval
- 2024-12-20
- Listings
- 3
- Application
- ANDA 202954
- Sponsor
- JUBILANT GENERICS
- Original approval
- 2025-03-06
- Listings
- 2
- Application
- NDA 210858
- Sponsor
- IBSA
- Original approval
- 2025-12-16
- Listings
- 8
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020895 | VIATRIS | 1998-03-27 | 9 |
| NDA 021845 | VIATRIS | 2005-06-03 | 2 |
| NDA 022473 | VIATRIS | 2009-11-18 | 1 |
| NDA 203109 | VIATRIS | 2012-08-30 | 1 |
| ANDA 091479 | TORRENT PHARMS LTD | 2012-11-06 | 9 |
| ANDA 202598 | CHARTWELL RX | 2012-11-06 | 1 |
| ANDA 078380 | TEVA PHARMS | 2013-01-07 | 1 |
| ANDA 202025 | AMNEAL PHARMS | 2013-02-28 | 9 |
| ANDA 203814 | MACLEODS PHARMS | 2013-12-17 | 12 |
| ANDA 203623 | HETERO LABS LTD V | 2014-11-26 | 7 |
| ANDA 203988 | EUGIA PHARMA | 2015-04-01 | 1 |
| ANDA 203963 | AUROBINDO PHARMA LTD | 2015-11-18 | 2 |
| ANDA 077342 | TEVA | 2016-03-09 | 6 |
| ANDA 204883 | RUBICON RESEARCH | 2016-06-20 | 6 |
| ANDA 210394 | AJANTA PHARMA LTD | 2018-05-04 | 9 |
| ANDA 204882 | RUBICON RESEARCH | 2018-06-11 | 7 |
| ANDA 091448 | TORRENT | 2018-06-11 | 12 |
| ANDA 203962 | AUROBINDO PHARMA LTD | 2018-06-11 | 10 |
| ANDA 202659 | HETERO LABS LTD V | 2018-06-11 | 25 |
| ANDA 202023 | AMNEAL PHARMS NY | 2018-06-27 | 6 |
| ANDA 206401 | AJANTA PHARMA LTD | 2018-10-12 | 18 |
| ANDA 211092 | AMNEAL PHARMS | 2019-11-27 | 2 |
| ANDA 212883 | AJANTA PHARMA LTD | 2019-11-27 | 1 |
| ANDA 207178 | APPCO | 2020-03-02 | 12 |
| ANDA 211534 | TEVA PHARMS USA | 2020-05-29 | 1 |
| ANDA 213032 | SUNSHINE | 2020-06-11 | 3 |
| ANDA 208494 | REYOUNG | 2020-06-12 | 6 |
| ANDA 209302 | UMEDICA | 2020-08-25 | 19 |
| ANDA 213814 | CHARTWELL RX | 2021-04-29 | 1 |
| ANDA 213014 | HETERO LABS LTD V | 2021-05-11 | 1 |
| ANDA 214641 | MSN | 2022-02-08 | 1 |
| ANDA 211638 | LUPIN | 2022-03-23 | 1 |
| ANDA 215708 | ZYDUS LIFESCIENCES | 2022-09-29 | 2 |
| ANDA 214773 | AUROBINDO PHARMA LTD | 2022-12-23 | 1 |
| ANDA 202255 | MACLEODS PHARMS | 2023-04-19 | 5 |
| ANDA 216383 | NOVITIUM PHARMA | 2023-08-29 | 3 |
| ANDA 218045 | CADILA PHARMS LTD | 2023-11-28 | 6 |
| ANDA 201156 | JUBILANT GENERICS | 2024-12-20 | 3 |
| ANDA 202954 | JUBILANT GENERICS | 2025-03-06 | 2 |
| NDA 210858 | IBSA | 2025-12-16 | 8 |
Showing 40 of 42 applications.
Official labeling on DailyMed
- SILDENAFIL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.] · version 7 · 2026-09-02
- SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 5 · 2026-09-02
- SILDENAFIL TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] · version 3 · 2026-09-02
- SILDENAFIL TABLET [PREFERRED PHARMACEUTICALS INC.] · version 5 · 2026-08-31
- SILDENAFIL TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 6 · 2026-08-25
- SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 8 · 2026-08-20
- SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] · version 2 · 2026-08-12
- SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 10 · 2026-08-12
- SILDENAFIL TABLET [BRYANT RANCH PREPACK] · version 1004 · 2026-08-11
- SILDENAFIL TABLET [A-S MEDICATION SOLUTIONS] · version 12 · 2026-08-11
- SILDENAFIL CITRATE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 13 · 2026-07-31
- SILDENAFIL CITRATE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 17 · 2026-07-31
Showing the 12 most recent of 165 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.