Application 020664

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOSTINEX	CABERGOLINE	TABLET;ORAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

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
N020664-001	DOSTINEX	CABERGOLINE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-12-23

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`a50c72e98297…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cabergoline	CABERGOLINE	Mylan Pharmaceuticals Inc.	e497366b-a124-4d7f-bd45-a883c392d4bb	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020664 application number: NDA020664 ndc (product): 59762-1005

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59762-1005	Cabergoline	cabergoline	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1005	Cabergoline	cabergoline	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1005	Cabergoline	cabergoline	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81996	SUPPL	2025-04-25
81991	SUPPL	2025-04-25
61309	SUPPL	2019-12-17
61284	SUPPL	2019-12-16
3030	SUPPL	2014-09-10
35105	SUPPL	2014-08-27
25469	SUPPL	2011-10-20
12948	SUPPL	2011-08-12
25468	SUPPL	2011-07-21
12947	SUPPL	2011-07-18
20808	ORIG	2010-01-05
25467	SUPPL	2008-01-09
35104	SUPPL	2007-12-27
3029	SUPPL	2007-02-23
12946	SUPPL	2007-02-21
25466	SUPPL	2006-12-28
35103	SUPPL	2006-12-14