FDA.reportPublic FDA data

Application 202503

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SILDENAFIL CITRATESILDENAFIL CITRATETABLET;ORALEQ 20MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202503-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202503-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202503-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202503-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68788-7379SildenafilSildenafil citratePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32268ORIG2012-11-07