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 5 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 QPharma Inc 85a638c3-d53c-453d-935c-fcfd31372a45 2025-12-03 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE QPharma, Inc. c0e147a8-36a6-1e61-e053-2a95a90afd62 2025-12-01 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE A-S Medication Solutions ae1fc2e6-cc67-4b90-9e39-d1ec4e9d6773 2025-11-02 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE A-S Medication Solutions 3911c18b-1259-4c6d-9466-73372eb7bd81 2025-11-02 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE A-S Medication Solutions 3325d1d4-84ca-4158-89ff-8c2185420ede 2025-11-02 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE A-S Medication Solutions 145355d0-6eea-4829-8756-644b6bc2ba73 2025-11-02 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE PD-Rx Pharmaceuticals, Inc. f4a4da81-c4d0-4a00-9f08-9029b5d9b5ea 2025-10-17 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Coupler LLC 3eee00d8-8606-e6bb-e063-6394a90a4a1e 2025-09-16 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE ProPharma Distribution 3ef0affa-a2f7-92de-e063-6294a90ad4d0 2025-09-16 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Advagen Pharma Ltd 3ecff825-34ea-4535-b935-627bf2c13d93 2025-09-12 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol METOPROLOL TARTRATE Fresenius Kabi USA, LLC be1c686e-37a5-4a53-945b-68a6ead35134 2025-09-12 Warnings, Adverse reactions Name fallback generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL NCS HealthCare of KY, LLC dba Vangard Labs c97e7527-b44e-48ca-b6be-53999bf5554b 2025-08-21 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Mylan Institutional Inc. 961248d5-d53c-408d-8f8f-d31885054f96 2025-07-22 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Bryant Ranch Prepack f8ac449a-d3b3-4f25-9e61-d91ef1230c72 2025-07-15 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Cardinal Health 107, LLC e93d7939-31ad-4fc5-a5f3-6d565cc6d0c1 2025-06-25 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Bryant Ranch Prepack 2338d4c3-ec2e-47f8-83cd-f43fed3ba7fb 2025-06-23 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Coupler LLC 37c9c12a-db53-1fd6-e063-6394a90afb92 2025-06-17 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE PD-Rx Pharmaceuticals, Inc. 00de1f16-f979-4dbf-aa60-246ffac8d410 2025-06-10 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Preferred Pharmaceuticals Inc. 4c6c75c5-9c80-44e1-bd16-b97509c9f542 2025-06-06 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE A-S Medication Solutions 7ac58d12-58bf-470d-8a5a-01a18c0c9209 2025-06-06 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