FDA.reportPublic FDA data

Application 091378

Type
ANDA
Sponsor
APOTEX CORP

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 3 of 3 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sildenafil CitrateSILDENAFIL CITRATEMylan Pharmaceuticals Inc.98a9897b-0cbc-4ea6-9ac2-4dd719a2ede02024-08-29Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFIL CITRATEAdvanced Rx Pharmacy of Tennessee, LLCf925abbe-4977-00b0-e053-6294a90a6e532024-07-10Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILAdvanced Rx of Tennessee, LLC1ceb575b-2687-0456-e063-6394a90aa88a2024-07-10Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
SILDENAFIL CITRATESILDENAFIL CITRATEA-S Medication Solutions6d79946b-72a9-4d1b-a84b-9d1a679a82e22024-06-18Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILNuCare Pharmaceuticals,Inc.0bb3eb8d-05cd-b4cd-e063-6294a90a94bb2024-05-15Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
SildenafilSILDENAFIL CITRATEANI Pharmaceuticals, Inc.083da718-e934-4941-b083-a19b4ebe39352024-01-22Warnings, Adverse reactionsName fallback
generic name: SILDENAFIL CITRATE
sildenafil citrateSILDENAFIL CITRATENovadoz Pharmaceuticals LLC18b327c1-19c9-4e33-ae02-de7cc900149c2024-01-01Warnings, Adverse reactionsName fallback
brand name: sildenafil citrate
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILProficient Rx LP88825206-1b91-4d95-876c-71100912d3782024-01-01Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
Sildenafil CitrateSILDENAFILA-S Medication Solutionsbf1a22a2-6a69-46c9-933d-e474e88637e92023-11-24Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
ViagraSILDENAFIL CITRATEViatris Specialty LLCd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e2023-11-17Warnings, Adverse reactionsName fallback
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILProficient Rx LPb9b1d6ee-da42-4ef2-ab93-cd36d7f341502023-10-01Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
Sildenafil CitrateSILDENAFIL CITRATEAscend Laboratories, LLCa0fa4162-e1b7-4293-ab7d-c5b3757790602023-09-25Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFIL CITRATEAsclemed USA, Inc.49a95b25-08b3-4cfe-a60b-c5132c280be22023-09-13Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFIL CITRATEANI Pharmaceuticals, Inc.6d8dbaa6-d61a-46ae-a641-f664104f47142023-09-05Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILAsclemed USA, Inc.0500a861-359f-4e12-beb5-0cac8cd6ae1c2023-05-10Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
RevatioSILDENAFIL CITRATEPFIZER LABORATORIES DIV PFIZER INCf158fe10-d5dc-4432-b2c9-fc665401291b2023-01-27Warnings, Adverse reactionsName fallback
generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP59b623bc-fbdd-4f32-8327-0d600763f4292022-11-01Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILTruPharma LLCc8864c64-22ad-402b-a1e8-cfb53fa02e802020-06-22Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
Sildenafil CitrateSILDENAFILProficient Rx LP9ebc1a11-3f4b-4eb3-89f5-f430a330887d2019-10-01Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
ViagraSILDENAFIL CITRATEPFIZER LABORATORIES DIV PFIZER INC0b0be196-0c62-461c-94f4-9a35339b45012017-12-15Warnings, Adverse reactionsName fallback
generic name: SILDENAFIL CITRATE

Reported adverse events (FAERS/openFDA)#

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