Application 078899

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BROMOCRIPTINE MESYLATE	BROMOCRIPTINE MESYLATE	CAPSULE;ORAL	EQ 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
A078899-001	BROMOCRIPTINE MESYLATE	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB		2008-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078899-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078899-001	BROMOCRIPTINE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	AB	2008-07-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078899-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078899-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078899-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078899-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078899-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078899-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078899-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078899-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078899-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078899-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078899-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078899-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078899-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078899-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078899-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078899-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078899-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078899-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078899-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078899-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078899-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078899-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078899-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078899-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078899-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078899-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078899-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078899-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078899-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078899-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078899-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078899-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078899-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078899-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078899-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078899-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078899-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078899-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078899-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078899-001	AB	1	`cb3db0bc1861…`

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 · 2 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	Exact identifier application applno (ANDA): 078899 application number: ANDA078899 ndc (product): 68382-110
Bromocriptine mesylate	BROMOCRIPTINE MESYLATE	Zydus Lifesciences Limited	97e7e051-ff64-4381-a869-6c1c364ad822	2024-11-25		Exact identifier application applno (ANDA): 078899 application number: ANDA078899 ndc (product): 65841-654

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-654	Bromocriptine mesylate	Bromocriptine mesylate	Cadila Healthcare Limited	ANDA	Current
65841-654	Bromocriptine mesylate	Bromocriptine mesylate	Zydus Lifesciences Limited	ANDA	Current
65841-654	Bromocriptine mesylate	Bromocriptine mesylate	Cadila Healthcare Limited	ANDA	Current
65841-654	Bromocriptine mesylate	Bromocriptine mesylate	Cadila Healthcare Limited	ANDA	Current
68382-110	Bromocriptine mesylate	Bromocriptine mesylate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-110	Bromocriptine mesylate	Bromocriptine mesylate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-110	Bromocriptine mesylate	Bromocriptine mesylate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-110	Bromocriptine mesylate	Bromocriptine mesylate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-110	Bromocriptine mesylate	Bromocriptine mesylate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-110	Bromocriptine mesylate	Bromocriptine mesylate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current