FDA.reportPublic FDA data

Application 200165

Type
ANDA
Sponsor
ACTAVIS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SILDENAFIL CITRATESILDENAFIL CITRATETABLET; ORAL25MGNoNo
002SILDENAFIL CITRATESILDENAFIL CITRATETABLET; ORAL50MGNoNo
003SILDENAFIL CITRATESILDENAFIL CITRATETABLET; ORAL100MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 3 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SILDENAFIL CITRATESILDENAFIL CITRATENorthstar Rx LLC8127ff38-2761-49ec-8ce7-7f971f521cfb2026-02-26Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFILTorrent Pharmaceuticals Limitedb48630b1-5208-4d00-b56f-21701f2237582026-02-10Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFIL CITRATEZydus Lifesciences Limited2ef4d02f-76ee-4f67-9f4f-1cd554decb312026-02-02Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
generic name: SILDENAFIL CITRATE
sildenafil CITRATESILDENAFIL CITRATEAurobindo Pharma Limitedb60b4fdc-9b78-45e6-8438-8a30f83ed9762026-02-02Warnings, Adverse reactionsName fallback
brand name: sildenafil CITRATE
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFIL CITRATEZydus Pharmaceuticals (USA) Inc.b2f04ce4-f19c-403d-8a83-74f123e5d30a2026-02-02Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILAdvagen Pharma Ltdce683bbc-a1d2-4f23-b3d1-d9333d91dc552026-01-13Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
Sildenafil CitrateSILDENAFILNorthwind Health Company, LLCd9ddfd2a-1961-90f9-e053-2a95a90a7f9b2026-01-01Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
SILDENAFIL CITRATESILDENAFILNorthwind Health Company, LLCd9de0817-cac1-4ee5-e053-2a95a90a5fa72026-01-01Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILQuallent Pharmaceuticals Health LLC41b67fd2-3d9a-49d6-88b8-285044b98dc12025-11-07Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP8780c159-8b61-402b-afbe-64f5c85d38862025-11-01Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP30ce6e7f-716e-4a68-a4fb-2bb2d34ed0522025-11-01Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILAjanta Pharma USA Inc.2ccc6fa6-f8ae-4191-806f-a887244e516a2025-10-08Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
SILDENAFIL CITRATESILDENAFIL CITRATEPD-Rx Pharmaceuticals, Inc.dc4430cc-8238-4d6d-99ff-bbb9d0b51bd12025-04-04Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFIL CITRATEAdvanced Rx of Tennessee, LLC30cb7d6a-ce40-c794-e063-6294a90a68612025-03-20Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILNuCare Pharmaceuticals,Inc.155c7549-b7d6-0c06-e063-6294a90ac65c2025-03-17Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
SILDENAFIL CITRATESILDENAFIL CITRATEPreferred Pharmaceuticals Inc.5846bff2-6a93-46a7-a547-04459c5908142025-01-20Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILNuCare Pharmaceuticals, Inc.1d614710-708e-f11c-e063-6394a90a05a52024-12-26Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
RevatioSILDENAFIL CITRATEViatris Specialty LLC3bb9363e-b28d-4019-8aae-539233dca2142024-12-18Warnings, Adverse reactionsName fallback
generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFIL CITRATEA-S Medication Solutions28a3376b-e50e-4789-9916-803ba29a15222024-10-25Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFIL CITRATENuCare Pharmaceuticals, Inc.20ead8ca-7cec-2d80-e063-6394a90af5482024-08-30Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
generic name: SILDENAFIL CITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.