Home Applications 076962 Application 076962
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE TABLET;ORAL EQ 2.5MG BASE 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 A076962-001 BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24
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 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2004-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2004-09-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2004-09-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2004-09-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076962-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL 2004-09-24 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 · 9 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bromocriptine mesylate BROMOCRIPTINE MESYLATE Zydus Pharmaceuticals USA Inc. d69003ee-0b6f-47a9-834e-ba59c02f566c 2026-07-28 Warnings, Adverse reactions Name fallback brand name: Bromocriptine mesylate generic name: BROMOCRIPTINE MESYLATE Bromocriptine Mesylate BROMOCRIPTINE MESYLATE ANI Pharmaceuticals, Inc. 17f3a343-1782-4799-95ba-31dfe93be2cf 2026-07-27 Warnings, Adverse reactions Name fallback brand name: Bromocriptine Mesylate generic name: BROMOCRIPTINE MESYLATE Bromocriptine Mesylate BROMOCRIPTINE MESYLATE American Health Packaging ddd292a5-72af-448f-8b88-cc4fd99ec783 2026-06-12 Warnings, Adverse reactions Name fallback brand name: Bromocriptine Mesylate generic name: BROMOCRIPTINE MESYLATE Bromocriptine mesylate BROMOCRIPTINE MESYLATE REMEDYREPACK INC. 29827cb6-f8fe-424f-80ef-48f4ef460122 2026-04-27 Warnings, Adverse reactions Name fallback brand name: Bromocriptine mesylate generic name: BROMOCRIPTINE MESYLATE CYCLOSET BROMOCRIPTINE MESYLATE Avvisto Therapeutics LLC e42ba916-16b9-4d1c-8d09-9d2fbb1b6c20 2026-01-12 Warnings, Adverse reactions Name fallback generic name: BROMOCRIPTINE MESYLATE Bromocriptine mesylate BROMOCRIPTINE MESYLATE Zydus Lifesciences Limited 97e7e051-ff64-4381-a869-6c1c364ad822 2024-11-25 Name fallback brand name: Bromocriptine mesylate generic name: BROMOCRIPTINE MESYLATE Bromocriptine mesylate BROMOCRIPTINE MESYLATE Sandoz Inc c43c300d-8aec-4020-984a-42c1a917c08f 2024-06-30 Warnings, Adverse reactions Name fallback brand name: Bromocriptine mesylate generic name: BROMOCRIPTINE MESYLATE Bromocriptine mesylate BROMOCRIPTINE MESYLATE Padagis US LLC 0ee2da00-faf8-4c51-a696-9462fa4f6050 2023-05-31 Warnings, Adverse reactions Name fallback brand name: Bromocriptine mesylate generic name: BROMOCRIPTINE MESYLATE Bromocriptine Mesylate BROMOCRIPTINE MESYLATE Mylan Pharmaceuticals Inc. 72d8eefe-c066-41b6-8922-9586f1cf47a1 2021-10-13 Warnings, Adverse reactions Name fallback brand name: Bromocriptine Mesylate generic name: BROMOCRIPTINE MESYLATE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-2042 Bromocriptine Mesylate bromocriptine mesylate Mylan Pharmaceuticals Inc. ANDA Current 0378-2042 Bromocriptine Mesylate bromocriptine mesylate Mylan Pharmaceuticals Inc. ANDA Current 0378-2042 Bromocriptine Mesylate bromocriptine mesylate Mylan Pharmaceuticals Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31179 ORIG 2004-09-29