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 6 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 f56a17b5-3a2e-4f77-89e0-e4a41d802031 2025-06-06 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE A-S Medication Solutions a2add754-0bd9-4f8a-ae05-b06d35d7f423 2025-06-06 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE A-S Medication Solutions d124cdfe-8250-41c1-badb-874b1060f735 2025-06-06 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Coupler LLC 3698837b-c34b-569a-e063-6394a90a167c 2025-06-02 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE A-S Medication Solutions 73563f90-4d1c-450b-b4d9-d39a1e39dcfd 2025-05-29 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE A-S Medication Solutions 0882d731-719d-4484-b2c8-88b04a4af67f 2025-05-28 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE A-S Medication Solutions b5645b28-d4b7-4671-a0c1-5e093f68f823 2025-05-28 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE LOPRESSOR METOPROLOL TARTRATE VALIDUS PHARMACEUTICALS LLC 9f448171-9588-4a54-88b3-5d870060ce86 2025-05-15 Warnings, Adverse reactions Name fallback generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE FOSUN PHARMA USA INC 1e787808-b3e0-417a-b333-80619d15432b 2025-04-30 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE NuCare Pharmaceuticals, Inc. 2760fbbc-ec68-4df8-e063-6394a90a15f5 2025-04-03 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOROPROLOL TARTRATE Hikma Pharmaceuticals USA Inc. c7ec36bb-bc6f-42de-9974-a50ac13e9410 2025-03-26 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Asclemed USA, Inc. e3de56de-b707-405e-bf97-837070e5c744 2025-03-18 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Preferred Pharmaceuticals Inc. 3ced6d8c-8a88-47dc-9f11-dddbd4c31609 2025-03-06 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Cardinal Health 107, LLC 17dbdf5f-d032-472a-9568-67689b08ef09 2025-03-05 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Proficient Rx LP de781298-37cb-4c03-8431-b6d86ffbde0d 2025-03-01 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE METOPROLOL TARTRATE METOPROLOL TARTRATE Bryant Ranch Prepack dce119e6-8909-41d1-8919-819b820ab68c 2025-01-31 Warnings, Adverse reactions Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Bryant Ranch Prepack bac92e34-efe3-4c20-a7bd-6a5382459f9c 2025-01-29 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Bryant Ranch Prepack bf81fdaa-a3e3-46d6-a8a2-3d9c6c508777 2025-01-29 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE Bryant Ranch Prepack ef003386-bfda-426e-9eb3-055035c29307 2025-01-29 Warnings, Adverse reactions Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE Metoprolol Tartrate METOPROLOL TARTRATE RedPharm Drug, Inc fcb2812b-37d2-de88-e053-6394a90ac2b5 2025-01-23 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