Home Applications 078459 Application 078459
Type ANDA
Sponsor IPCA LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 25MG No No 002 METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 50MG No No 003 METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET;ORAL 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078459-001 METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 A078459-002 METOPROLOL TARTRATE METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 A078459-003 METOPROLOL TARTRATE METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 2026-09-14 22:38:34 2026-08 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078459-002 METOPROLOL TARTRATE 50MG TABLET / ORAL AB 2008-06-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078459-003 METOPROLOL TARTRATE 100MG TABLET / ORAL AB 2008-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078459-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2008-06-17 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 3 of 9 · 171 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join METOPROLOL TARTRATE METOPROLOL TARTRATE A-S Medication Solutions ef6a817b-58c5-45bc-b5a2-22c31b05c0ab 2026-05-19 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE A-S Medication Solutions 2bcfb9d9-e092-4a0a-ac55-bad532de360c 2026-05-19 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE ASCLEMED USA INC. df3492c3-b71a-40d8-838b-031ebca969d8 2026-05-18 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL Coupler LLC 512711ea-a3be-6de6-e063-6394a90a9109 2026-05-06 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Hospira, Inc. f65e93ec-4db6-44fa-bff1-8ae89aa8243f 2026-05-04 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOROPROLOL TARTRATE Civica, Inc. 8dae76a2-32e7-40a2-bb70-9c6380b9b330 2026-04-19 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate METOPROLOL TARTRATE METOPROLOL TARTRATE NuCare Pharmaceuticals, Inc. 4f9ba91b-ecfc-10cc-e063-6294a90ae236 2026-04-16 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE ST. MARY'S MEDICAL PARK PHARMACY 4f845cbb-81a2-72c4-e063-6394a90a96d6 2026-04-15 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE QPharma, Inc. 4dcb79e6-19de-67fb-e063-6294a90afde0 2026-04-10 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Bryant Ranch Prepack 840ac287-cae5-4c07-82d5-546fb04414ef 2026-04-09 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Bryant Ranch Prepack 22f1b399-83ad-4c2e-bb17-c11967a7471e 2026-04-09 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL Proficient Rx LP 95b95aab-0733-4189-b4c0-429a1046c534 2026-04-01 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Redpharm Drug 4ce1c1ef-bc9a-1397-e063-6294a90a3bda 2026-03-13 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE PD-Rx Pharmaceuticals, Inc. 4cdbfc5d-2572-39b0-e063-6394a90af5f2 2026-03-12 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Legacy Pharmaceutical Packaging, LLC 20cc66c0-a00b-4643-9819-6e0daed51e5f 2026-03-11 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Bryant Ranch Prepack 77fb1898-871f-489f-bc0b-933dd08a9bc4 2026-03-11 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Direct_Rx 13b7404f-e16b-5d43-e063-6394a90a3fca 2026-03-05 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Exelan Pharmaceuticals, Inc. f54b250d-bd15-483b-b191-a664291382c1 2026-02-27 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE A-S Medication Solutions e1bb16fa-4f72-44bc-bc33-d7653c13f55c 2026-02-04 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE A-S Medication Solutions 5b423eba-0a35-41b0-9338-fa4c6f5c6c7f 2026-02-04 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
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 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50436-3155 Metoprolol Tartrate Metoprolol Tartrate Unit Dose Services ANDA Current 50436-6578 Metoprolol Tartrate Metoprolol Tartrate Unit Dose Services ANDA Current 53808-1018 Metoprolol Tartrate Metoprolol Tartrate State of Florida DOH Central Pharmacy ANDA Current 63304-579 Metoprolol Tartrate Metoprolol Tartrate Ranbaxy Pharmaceuticals Inc. ANDA Current 63304-580 Metoprolol Tartrate Metoprolol Tartrate Ranbaxy Pharmaceuticals Inc. ANDA Current 63304-581 Metoprolol Tartrate Metoprolol Tartrate Ranbaxy Pharmaceuticals Inc. ANDA Current 63629-1462 Metoprolol Tartrate Metoprolol Tartrate Bryant Ranch Prepack ANDA Current 64725-0579 Metoprolol Tartrate Metoprolol Tartrate TYA Pharmaceuticals ANDA Current 67046-473 Metoprolol tartrate metoprolol tartrate Contract Pharmacy Services-PA ANDA Current 67046-474 Metoprolol Tartrate Metoprolol tartrate Contract Pharmacy Services-PA ANDA Current 68788-9686 Metoprolol Tartrate Metoprolol Tartrate Preferred Pharmaceuticals, Inc. ANDA Current