FDA.reportPublic FDA data

Application 074418

Type
ANDA
Sponsor
OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAPTOPRILCAPTOPRILTABLET;ORAL12.5MGNoNo
002CAPTOPRILCAPTOPRILTABLET;ORAL25MGNoNo
003CAPTOPRILCAPTOPRILTABLET;ORAL50MGNoNo
004CAPTOPRILCAPTOPRILTABLET;ORAL100MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074418-001CAPTOPRILCAPTOPRIL12.5MGTABLET / ORAL1996-02-13
A074418-002CAPTOPRILCAPTOPRIL25MGTABLET / ORAL1996-02-13
A074418-003CAPTOPRILCAPTOPRIL50MGTABLET / ORAL1996-02-13
A074418-004CAPTOPRILCAPTOPRIL100MGTABLET / ORAL1996-02-13

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 22:54:322026-06A074418-001CAPTOPRIL12.5MGTABLET / ORAL1996-02-13a50c72e98297…
2026-08-01 22:54:322026-06A074418-002CAPTOPRIL25MGTABLET / ORAL1996-02-13a50c72e98297…
2026-08-01 22:54:322026-06A074418-003CAPTOPRIL50MGTABLET / ORAL1996-02-13a50c72e98297…
2026-08-01 22:54:322026-06A074418-004CAPTOPRIL100MGTABLET / ORAL1996-02-13a50c72e98297…

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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CaptoprilCAPTOPRILBryant Ranch Prepack563737c5-4d63-4957-8022-e3bc3112dfac2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILBryant Ranch Prepack66604c8e-f6b6-4cf9-9561-f1cb4af0e0d62026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILMajor Pharmaceuticalsa43a5373-ded9-4912-8c98-edaec83528362026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILAiPing Pharmaceutical, Inc.3b789f16-b291-4012-be39-af3beec3ff9a2026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILSolco Healthcare US, LLC2d3779b0-83d9-4b6f-a043-f7768cd7fce62025-12-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
captoprilCAPTOPRILMethod Pharmaceuticals LLC1a91ac7f-b75d-d111-e063-6394a90a2a932025-12-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILAjanta Pharma USA Inc.1fbc9b28-ff10-4b17-a359-e12b4330747e2025-11-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILGolden State Medical Supply, Inc.d117c8bd-50a8-7355-e053-2a95a90ac70f2025-11-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
captoprilCAPTOPRILBryant Ranch Prepackccbffd30-4b21-4522-bdb8-abba8d5920172025-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILAvKARE3362b7a8-026a-b277-e063-6394a90a9dc62025-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILPD-Rx Pharmaceuticals, Inc.65ed6e70-f1ee-437e-965c-d1b1fdadd8322025-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILHikma Pharmaceuticals USA Inc.607687f4-63cf-411c-a20b-21d238a6b7a72024-12-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILAmerican Health Packaging9b54feb0-13cd-46a8-9924-f128803811962024-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILCamber Pharmaceuticals, Inc.5b44ab6e-6cd9-4e12-b9be-d2e4d954acb52023-12-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
captoprilCAPTOPRILAMICI PHARMACEUTICALS LLC1395ba5b-2fc9-41ff-9c43-e0740d781dee2022-09-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: captopril
generic name: CAPTOPRIL