Home Applications 091276 Application 091276
Type ANDA
Sponsor GLENMARK GENERICS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 INDOMETHACIN INDOMETHACIN CAPSULE;ORAL 25MG No No 002 INDOMETHACIN INDOMETHACIN CAPSULE;ORAL 50MG No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091276-001 INDOMETHACIN INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 A091276-002 INDOMETHACIN INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
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 2 of 2 · 21 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 2 of 2 · 132 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68462-406 Indomethacin Indomethacin Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-406 Indomethacin Indomethacin Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-406 Indomethacin Indomethacin Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-406 Indomethacin Indomethacin Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-406 Indomethacin Indomethacin Glenmark Pharmaceuticals Inc., USA ANDA Current 68462-406 Indomethacin Indomethacin Glenmark Pharmaceuticals Inc., USA ANDA Current 68788-6448 Indomethacin Indomethacin Preferred Pharmaceuticals Inc. ANDA Current 68788-6448 Indomethacin Indomethacin Preferred Pharmaceuticals Inc. ANDA Current 68788-6448 Indomethacin Indomethacin Preferred Pharmaceuticals Inc. ANDA Current 68788-6448 Indomethacin Indomethacin Preferred Pharmaceuticals Inc. ANDA Current 68788-6448 Indomethacin Indomethacin Preferred Pharmaceuticals Inc. ANDA Current 68788-6983 Indomethacin Indomethacin Preferred Pharmaceuticals Inc. ANDA Current 68788-6983 Indomethacin Indomethacin Preferred Pharmaceuticals Inc. ANDA Current 68788-6983 Indomethacin Indomethacin Preferred Pharmaceuticals Inc. ANDA Current 68788-6983 Indomethacin Indomethacin Preferred Pharmaceuticals Inc. ANDA Current 68788-6983 Indomethacin Indomethacin Preferred Pharmaceuticals Inc. ANDA Current 70518-0254 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-0254 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-0254 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-0254 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-0254 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-0254 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1458 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1458 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1458 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1458 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1458 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1512 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1512 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1512 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1512 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1512 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1512 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1512 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70518-1512 Indomethacin Indomethacin REMEDYREPACK INC. ANDA Current 70934-181 Indomethacin Indomethacin Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-181 Indomethacin Indomethacin Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-181 Indomethacin Indomethacin Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 70934-395 Indomethacin Indomethacin Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-395 Indomethacin Indomethacin Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 70934-395 Indomethacin Indomethacin Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 70934-527 Indomethacin Indomethacin Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 71205-159 Indomethacin Indomethacin Proficient Rx LP ANDA Current 71205-159 Indomethacin Indomethacin Proficient Rx LP ANDA Current 71205-159 Indomethacin Indomethacin Proficient Rx LP ANDA Current 71205-159 Indomethacin Indomethacin Proficient Rx LP ANDA Current 71335-0107 Indomethacin Indomethacin Bryant Ranch Prepack ANDA Current 71335-0107 Indomethacin Indomethacin Bryant Ranch Prepack ANDA Current 71335-0107 Indomethacin Indomethacin Bryant Ranch Prepack ANDA Current 71335-0355 Indomethacin Indomethacin Bryant Ranch Prepack ANDA Current 71335-0355 Indomethacin Indomethacin Bryant Ranch Prepack ANDA Current 71335-0355 Indomethacin Indomethacin Bryant Ranch Prepack ANDA Current