FDA — authorised 19 November 2010
- Application: NDA022473
- Marketing authorisation holder: VIATRIS
- Indication: Labeling
- Status: approved
🇺🇸 Viagra in United States
FDA authorised Viagra on 19 November 2010 · 20,814 US adverse-event reports
Marketing authorisations
FDA — authorised 6 November 2012
- Application: ANDA202503
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 November 2012
- Application: ANDA091479
- Marketing authorisation holder: TORRENT PHARMS LTD
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 November 2012
- Application: ANDA202598
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 2013
- Application: ANDA078380
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 2013
- Application: ANDA200149
- Marketing authorisation holder: ACTAVIS GRP PTC
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 November 2014
- Application: ANDA203623
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 April 2015
- Application: ANDA203988
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: SILDENAFIL CITRATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 18 November 2015
- Application: ANDA203963
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 March 2016
- Application: ANDA077342
- Marketing authorisation holder: TEVA
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 May 2018
- Application: ANDA210394
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 June 2018
- Application: ANDA091448
- Marketing authorisation holder: TORRENT
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 June 2018
- Application: ANDA203962
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 October 2018
- Application: ANDA206401
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2019
- Application: ANDA212051
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 2019
- Application: ANDA212440
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: SILDENAFIL CITRATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 November 2019
- Application: ANDA211092
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: SILDENAFIL CITRATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 November 2019
- Application: ANDA212883
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: SILDENAFIL CITRATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 2 March 2020
- Application: ANDA207178
- Marketing authorisation holder: APPCO
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 2020
- Application: ANDA209302
- Marketing authorisation holder: UMEDICA
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 November 2020
- Application: ANDA202506
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 2022
- Application: ANDA214641
- Marketing authorisation holder: MSN
- Status: approved
FDA — authorised 29 September 2022
- Application: ANDA215708
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: SILDENAFIL CITRATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 December 2022
- Application: ANDA214773
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: SILDENAFIL CITRATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 April 2023
- Application: ANDA202255
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 August 2023
- Application: ANDA216383
- Marketing authorisation holder: NOVITIUM PHARMA
- Status: approved
FDA — authorised 8 July 2024
- Application: ANDA212260
- Marketing authorisation holder: NOVITIUM PHARMA
- Indication: Labeling
- Status: approved
NOVITIUM PHARMA was granted marketing authorisation by the FDA for Viagra on 2024-07-08. The application number for this approval is ANDA212260. Viagra is approved for its labelled indication, but the specific local brand name is not reported. The approval was granted through the standard expedited pathway.
FDA — authorised 6 March 2025
- Application: ANDA202954
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 2025
- Application: NDA210858
- Marketing authorisation holder: IBSA
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved IBSA's application (NDA210858) for Viagra, a new dosage form, on 16 December 2025. This approval was granted under the standard expedited pathway. Viagra is indicated for the treatment of erectile dysfunction.
FDA
- Application: ANDA200165
- Marketing authorisation holder: ACTAVIS PHARMA
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA202597
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: SILDENAFIL CITRATE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 20,814
Most-reported reactions
- Drug Ineffective — 9,186 reports (44.13%)
- Erection Increased — 2,980 reports (14.32%)
- Headache — 1,899 reports (9.12%)
- Malignant Melanoma — 1,252 reports (6.02%)
- Erectile Dysfunction — 1,203 reports (5.78%)
- Dizziness — 870 reports (4.18%)
- Fatigue — 863 reports (4.15%)
- Death — 859 reports (4.13%)
- Ejaculation Disorder — 853 reports (4.1%)
- Pain — 849 reports (4.08%)
Viagra in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Viagra approved in United States?
Yes. FDA authorised it on 19 November 2010; FDA authorised it on 6 November 2012; FDA authorised it on 6 November 2012.
Who is the marketing authorisation holder for Viagra in United States?
VIATRIS holds the US marketing authorisation.