Application 017962

Type: NDA
Sponsor: US PHARMS HOLDINGS I

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PARLODEL	BROMOCRIPTINE MESYLATE	TABLET;ORAL	EQ 2.5MG BASE	Yes	No
002	PARLODEL	BROMOCRIPTINE MESYLATE	CAPSULE;ORAL	EQ 5MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017962-001	PARLODEL	BROMOCRIPTINE MESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982
N017962-002	PARLODEL	BROMOCRIPTINE MESYLATE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N017962-001	AB
N017962-002	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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N017962-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017962-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017962-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017962-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017962-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017962-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017962-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017962-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017962-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017962-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017962-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017962-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017962-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017962-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017962-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017962-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017962-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017962-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017962-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017962-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017962-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017962-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017962-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017962-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017962-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017962-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017962-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017962-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017962-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017962-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017962-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017962-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017962-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017962-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017962-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017962-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017962-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017962-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017962-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017962-002	AB	1	`4b0b4de00fa7…`

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	ANI Pharmaceuticals, Inc.	17f3a343-1782-4799-95ba-31dfe93be2cf	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017962 application number: NDA017962
Bromocriptine Mesylate	BROMOCRIPTINE MESYLATE	American Health Packaging	ddd292a5-72af-448f-8b88-cc4fd99ec783	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017962 application number: NDA017962

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30698-201	Parlodel	bromocriptine mesylate	Validus Pharmaceuticals LLC	NDA	Current
30698-201	Parlodel	bromocriptine mesylate	Validus Pharmaceuticals LLC	NDA	Current
30698-201	Parlodel	bromocriptine mesylate	Validus Pharmaceuticals LLC	NDA	Current
30698-202	Parlodel	bromocriptine mesylate	Validus Pharmaceuticals LLC	NDA	Current
30698-202	Parlodel	bromocriptine mesylate	Validus Pharmaceuticals LLC	NDA	Current
30698-202	Parlodel	bromocriptine mesylate	Validus Pharmaceuticals LLC	NDA	Current
63304-158	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	Sun Pharmaceutical Industries, Inc.	NDA	Current
63304-158	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	Sun Pharmaceutical Industries, Inc.	NDA	Current
63304-962	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	Sun Pharmaceutical Industries, Inc.	NDA	Current
63304-962	BROMOCRIPTINE MESYLATE	bromocriptine mesylate	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68071	SUPPL	2021-07-14
68064	SUPPL	2021-07-13
61509	SUPPL	2020-01-03
61306	SUPPL	2019-12-17
33376	SUPPL	2012-01-06
13964	SUPPL	2012-01-06
13963	SUPPL	2012-01-06
11098	SUPPL	2012-01-06
40765	SUPPL	2006-05-08
20097	SUPPL	2006-05-08
33375	SUPPL	2005-11-17
13962	SUPPL	2005-11-17
13961	SUPPL	2005-11-17
11097	SUPPL	2005-11-17