FDA.reportPublic FDA data

Application 202572

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDOMETHACININDOMETHACINCAPSULE, EXTENDED RELEASE;ORAL75MGNoNo

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
A202572-001INDOMETHACININDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2013-12-09

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 22:54:322026-06A202572-001INDOMETHACIN75MGCAPSULE, EXTENDED RELEASE / ORAL2013-12-09a50c72e98297…

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 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndomethacinINDOMETHACINREMEDYREPACK INC.bf93022c-a965-49c5-a852-c59e580d7d912026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINSt. Mary's Medical Park Pharmacy205fc4e7-e118-509e-e063-6394a90a78e62026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINREMEDYREPACK INC.b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf302026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.009097a5-2c1e-4f5d-8054-896cf896cb3d2026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.99d7a84b-c755-47be-9d2d-1223162b0a422026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.ce866d3a-7bea-4d82-9b7d-79e8a294c1412026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.d66ada00-3ece-4b71-8c59-a0db48a2db802026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINBryant Ranch Prepackbf11f5a0-f2ee-499a-8d54-9d557cc668412026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINA-S Medication Solutionsd2997707-1541-4f5d-8c8d-70b0a13be8b22026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINPreferred Pharmaceuticals, Inc.3785c914-0037-49ef-b6f5-a5e868ae490b2026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINPreferred Pharmaceuticals Inc.1bb80a9f-def3-4228-ab04-a0c2a117a2b92026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINCoupler LLC51266787-b50e-bc15-e063-6394a90ad16f2026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINSt. Mary's Medical Park Pharmacy6312c9a6-d4d3-eb1f-e053-2991aa0a5e682026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINPD-Rx Pharmaceuticals, Inc.b4cf01d1-0d71-4f0f-97a5-07a59744149f2026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINREMEDYREPACK INC.16238287-d4b0-4afa-8483-1f4ae250a6252026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINSportpharm LLC12821a3a-b5f2-4415-84c9-0a30a4725f1e2026-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
INDOMETHACININDOMETHACINBryant Ranch Prepack41af7776-36bc-4820-b635-e7c69f26997e2026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: INDOMETHACIN
generic name: INDOMETHACIN
INDOMETHACININDOMETHACINDIRECT RX7e7175d7-5e43-4151-9702-88ac2cd44ef62026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: INDOMETHACIN
generic name: INDOMETHACIN
IndomethacinINDOMETHACINANI Pharmaceuticals, Inc.e8b86758-6cb5-44ac-a5fc-2111e98a19a82026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN
IndomethacinINDOMETHACINRedPharm Drug, Inc.4d9ef14a-4812-4fcf-e054-00144ff8d46c2026-01-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Indomethacin
generic name: INDOMETHACIN