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 7 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 RedPharm Drug, Inc 09d23356-ddf9-4dbd-e063-6394a90a217a 2025-01-23 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol METOPROLOL TARTRATE Cardinal Health 107, LLC d6ae40f1-bc7d-4d3a-b2e9-8d4fc4d1d759 2025-01-15 Warnings, Adverse reactions Name fallback generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE A-S Medication Solutions e2dd30a3-d6b4-4d65-ae61-431da1de5c14 2025-01-08 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE A-S Medication Solutions 2d12189f-bbd3-45fa-8553-870147eda96e 2025-01-08 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE A-S Medication Solutions 56b1de7b-3246-4a5e-a9a1-8970397e901c 2025-01-08 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE A-S Medication Solutions 8739b5c6-36ce-435f-b006-be8216c1c3dc 2024-12-27 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE TruPharma LLC 52c822f2-4a71-4ab2-a470-58074622846a 2024-12-15 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Proficient Rx LP 3c43fe89-2283-482e-9d97-648d3ed183f8 2024-12-01 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE A-S Medication Solutions 1137b967-21f5-404b-8505-83ca084ddb3c 2024-10-22 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE A-S Medication Solutions 771c262d-e1db-4a75-9609-110c27c43e51 2024-10-22 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Almaject, Inc. f0370951-ab26-d4d1-b857-57518f3c4175 2024-10-15 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE A-S Medication Solutions f4e88ecc-2d9b-4bad-97dd-77b1cbb75eb0 2024-10-03 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Proficient Rx LP 5a4969d2-d569-4d2b-b698-092f07bd055a 2024-10-01 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE TRUPHARMA LLC 92ab5942-823d-43aa-8e7a-56844ab8946f 2024-09-18 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Bryant Ranch Prepack 6c7fa479-bd5f-43df-b0ab-8d8a5fd87e13 2024-08-27 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL Alembic Pharmaceuticals Inc. 24837d82-0f3f-4482-9af0-31e5f675c30f 2024-08-22 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE A-S Medication Solutions 70c2fada-d604-4d0c-9b3c-1f21737a77d7 2024-07-23 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE NuCare Pharmaceuticals,Inc. a2669da1-b712-5fd5-e053-2a95a90a52f3 2024-06-20 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE NuCare Pharmaceuticals,Inc. 8cce6c9a-2457-18cd-e053-2995a90a3af2 2024-06-18 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE NuCare Pharmaceuticals,Inc. 8cf0a64b-1f97-29a2-e053-2a95a90a0afd 2024-06-18 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