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 1 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SILDENAFIL CITRATESILDENAFIL CITRATEPD-Rx Pharmaceuticals, Inc.00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b2026-07-29Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFIL CITRATEPD-Rx Pharmaceuticals, Inc.f1122baa-8dee-43fc-bd3d-501a55b696b32026-07-29Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
SildenafilSILDENAFIL CITRATEYaral Pharma Inc.a17a970e-25a2-4807-9644-74e6d2bd23832026-07-17Warnings, Adverse reactionsName fallback
generic name: SILDENAFIL CITRATE
VybriqueSILDENAFIL CITRATEIBSA Pharma Inc.9213fec1-e0c0-4ef7-9718-d97922a3f4d82026-07-08Warnings, Adverse reactionsName fallback
generic name: SILDENAFIL CITRATE
SildenafilSILDENAFIL CITRATEEugia US LLCbb92d686-a81e-4b91-8048-693af0534cb32026-07-01Warnings, Adverse reactionsName fallback
generic name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILNorthwind Health Company, LLC471b8574-cb2a-1670-e063-6394a90a2a842026-06-23Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
Sildenafil CitrateSILDENAFILBryant Ranch Prepack824dcd79-bc82-4b3a-8028-3c1bca1a7a0a2026-06-18Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
Sildenafil CitrateSILDENAFILProficient Rx LP3522bdcc-8113-4562-8ca1-f3eb884beaea2026-06-01Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.ace2bb56-4992-49fe-9311-535b12eea9b42026-05-27Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFILPD-Rx Pharmaceuticals, Inc.78c4551c-b922-43c9-9a5a-66377ea07bc22026-05-27Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFILRedpharm Drug52614168-3a9e-335d-e063-6394a90ac27f2026-05-22Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFILNuCare Pharmaceuticals, Inc.36da8e3a-d17c-e42f-e063-6394a90a1ece2026-05-18Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFIL CITRATEUmedica Laboratories USA Inc.90477a51-63ba-43f4-a74b-4659a946093c2026-05-13Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFIL CITRATENIVAGEN PHARMACEUTICALS, INC.5ac95dd0-57e4-495c-bf8d-b2e5bbe33e202026-04-27Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
generic name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFILPreferred Pharmaceuticals Inc.5f9ff0bb-5634-437a-96eb-249b910c7e812026-04-22Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
SILDENAFIL CITRATESILDENAFILBryant Ranch Prepacka05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d62026-03-30Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
Sildenafil CitrateSILDENAFILNuCare Pharmaceuticals,Inc.fbe75c2c-0aff-9ade-e053-6394a90a1ea42026-03-20Warnings, Adverse reactionsName fallback
brand name: Sildenafil Citrate
SILDENAFIL CITRATESILDENAFILBryant Ranch Prepackedb0919d-cbf1-4968-b0eb-342aa811c2ce2026-03-09Warnings, Adverse reactionsName fallback
brand name: SILDENAFIL CITRATE
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