Home Applications 076670 Application 076670
Type ANDA
Sponsor SUN PHARM INDS INC 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076670-001 METOPROLOL TARTRATE METOPROLOL TARTRATE 25MG TABLET / ORAL 2004-01-15
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL 2004-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL 2004-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL 2004-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076670-001 METOPROLOL TARTRATE 25MG TABLET / ORAL AB 2004-01-15 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 34 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-494 Metoprolol Tartrate Metoprolol tartrate Rebel Distributors Corp. ANDA Current 48433-313 Metoprolol Tartrate Metoprolol tartrate Safecor Health, LLC ANDA Current 48433-313 Metoprolol Tartrate Metoprolol tartrate Safecor Health, LLC ANDA Current 49999-575 Metoprolol Tartrate Metoprolol tartrate Lake Erie Medical DBA Quality Care Products LLC ANDA Current 49999-575 Metoprolol Tartrate Metoprolol tartrate Lake Erie Medical DBA Quality Care Products LLC ANDA Current 49999-575 Metoprolol Tartrate Metoprolol tartrate Lake Erie Medical DBA Quality Care Products LLC ANDA Current 49999-575 Metoprolol Tartrate Metoprolol tartrate Lake Erie Medical DBA Quality Care Products LLC ANDA Current 53808-0659 Metoprolol Tartrate METOPROLOL TARTRATE State of Florida DOH Central Pharmacy ANDA Current 57664-506 Metoprolol tartrate Metoprolol tartrate Sun Pharmaceutical Industries, Inc. ANDA Current 57664-506 Metoprolol tartrate Metoprolol tartrate Sun Pharmaceutical Industries, Inc. ANDA Current 57664-506 Metoprolol tartrate Metoprolol tartrate Sun Pharmaceutical Industries, Inc. ANDA Current 57664-506 Metoprolol tartrate Metoprolol tartrate Sun Pharmaceutical Industries, Inc. ANDA Current 57664-506 Metoprolol tartrate Metoprolol tartrate Sun Pharmaceutical Industries, Inc. ANDA Current 57664-506 Metoprolol tartrate Metoprolol tartrate Sun Pharmaceutical Industries, Inc. ANDA Current 58118-0361 Metoprolol tartrate Metoprolol tartrate Clinical Solutions Wholesale, LLC ANDA Current 58118-0361 Metoprolol tartrate Metoprolol tartrate Clinical Solutions Wholesale, LLC ANDA Current 58118-0361 Metoprolol tartrate Metoprolol tartrate Clinical Solutions Wholesale, LLC ANDA Current 61919-052 METOPROLOL TARTRATE METOPROLOL TARTRATE DIRECT RX ANDA Current 61919-052 METOPROLOL TARTRATE METOPROLOL TARTRATE Direct_Rx ANDA Current 61919-052 METOPROLOL TARTRATE METOPROLOL TARTRATE Direct_Rx ANDA Current 61919-052 METOPROLOL TARTRATE METOPROLOL TARTRATE Direct_Rx ANDA Current 63187-103 Metoprolol Tartrate Metoprolol tartrate Proficient Rx LP ANDA Current 63187-103 Metoprolol Tartrate Metoprolol tartrate Proficient Rx LP ANDA Current 63187-174 Metoprolol Tartrate Metoprolol tartrate Proficient Rx LP ANDA Current 63187-174 Metoprolol Tartrate Metoprolol tartrate Proficient Rx LP ANDA Current 63629-4605 Metoprolol Tartrate Metoprolol tartrate Bryant Ranch Prepack ANDA Current 67296-0729 Metoprolol tartrate Metoprolol tartrate RedPharm Drug, Inc. ANDA Current 67296-0729 Metoprolol tartrate Metoprolol tartrate RedPharm Drug, Inc. ANDA Current 67544-387 Metoprolol tartrate Metoprolol tartrate Aphena Pharma Solutions - Tennessee, LLC ANDA Current 67544-387 Metoprolol tartrate Metoprolol tartrate Aphena Pharma Solutions - Tennessee, LLC ANDA Current 68071-3263 Metoprolol tartrate Metoprolol tartrate NuCare Pharmaceuticals, Inc. ANDA Current 68258-6033 Metoprolol Tartrate Metoprolol tartrate Dispensing Solutions, Inc. ANDA Current 68788-9286 Metoprolol Tartrate Metoprolol tartrate Preferred Pharmaceuticals, Inc. ANDA Current 70518-3475 Metoprolol tartrate Metoprolol tartrate REMEDYREPACK INC. ANDA Current