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 2 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 1 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 REMEDYREPACK INC. 0ca72c89-82c5-4b31-b515-1a8b8e82ec59 2026-09-10 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE REMEDYREPACK INC. 621249c4-531b-4138-9bde-77a06ad7816b 2026-09-03 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Redpharm Drug 59ed1885-cc00-5325-e063-6294a90a50c2 2026-08-26 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL Redpharm Drug 59ed27b8-32b5-60c0-e063-6394a90a8a23 2026-08-26 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL REMEDYREPACK INC. 58d493d3-b69c-422a-b6a8-0f8fa1e55545 2026-08-17 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL Northwind Health Company, LLC 106b7a0c-af7f-2565-e063-6294a90a34e0 2026-08-17 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE PD-Rx Pharmaceuticals, Inc. cbcec1e7-7eac-456e-a253-aaf6761b4883 2026-08-11 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE REMEDYREPACK INC. c9ccdbc0-0e4e-40c4-aacf-de60deda9fd5 2026-08-06 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE REMEDYREPACK INC. 3a236293-35c1-4083-9805-ab40df535083 2026-08-06 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE REMEDYREPACK INC. 58239cf1-53b4-4ef7-e063-6394a90a65bd 2026-08-03 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Proficient Rx LP 4871791a-7679-4345-8fd6-fdb9c9217352 2026-08-01 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Cardinal Health 107, LLC 6399f2c3-7799-4f8b-b8b7-8d2137b1f852 2026-07-28 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE REMEDYREPACK INC. 028b6e4a-1597-4d21-89d0-0bbbad21efa8 2026-07-27 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL Bryant Ranch Prepack 00940cc5-d2eb-4841-9138-de97d7b1c674 2026-07-27 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL Northwind Health Company, LLC 471ccbfe-96dd-7ab9-e063-6394a90a5bd6 2026-07-21 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Aphena Pharma Solutions - Tennessee, LLC 5476c4fc-ab09-ee1a-e063-6394a90a7a1b 2026-07-13 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Cardinal Health 107, LLC 0ccb9d3c-3f9a-486d-9b27-dc6f3ef6f4ed 2026-07-10 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Safecor Health, LLC 63d45147-9b37-40e2-9619-cd1a3e77ff31 2026-07-10 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Bryant Ranch Prepack a590edb1-3310-49e3-b3d1-dbbb3f81f1c1 2026-07-10 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE American Health Packaging 0a3ccfd4-8b65-4c7e-b0ba-27ff40d5b5e8 2026-07-02 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