Application 019385

Type: NDA
Sponsor: VALEANT PHARM INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PERMAX	PERGOLIDE MESYLATE	TABLET;ORAL	EQ 0.05MG BASE	No	No
002	PERMAX	PERGOLIDE MESYLATE	TABLET;ORAL	EQ 0.25MG BASE	No	No
003	PERMAX	PERGOLIDE MESYLATE	TABLET;ORAL	EQ 1MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N019385-001	PERMAX	PERGOLIDE MESYLATE	EQ 0.05MG BASE	TABLET / ORAL	1988-12-30
N019385-002	PERMAX	PERGOLIDE MESYLATE	EQ 0.25MG BASE	TABLET / ORAL	1988-12-30
N019385-003	PERMAX	PERGOLIDE MESYLATE	EQ 1MG BASE	TABLET / ORAL	1988-12-30

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N019385-001	PERMAX	EQ 0.05MG BASE	TABLET / ORAL	1988-12-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N019385-002	PERMAX	EQ 0.25MG BASE	TABLET / ORAL	1988-12-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N019385-003	PERMAX	EQ 1MG BASE	TABLET / ORAL	1988-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019385-001	PERMAX	EQ 0.05MG BASE	TABLET / ORAL	1988-12-30	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N019385-002	PERMAX	EQ 0.25MG BASE	TABLET / ORAL	1988-12-30	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N019385-003	PERMAX	EQ 1MG BASE	TABLET / ORAL	1988-12-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019385-001	PERMAX	EQ 0.05MG BASE	TABLET / ORAL	1988-12-30	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019385-002	PERMAX	EQ 0.25MG BASE	TABLET / ORAL	1988-12-30	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019385-003	PERMAX	EQ 1MG BASE	TABLET / ORAL	1988-12-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019385-001	PERMAX	EQ 0.05MG BASE	TABLET / ORAL	1988-12-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019385-002	PERMAX	EQ 0.25MG BASE	TABLET / ORAL	1988-12-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019385-003	PERMAX	EQ 1MG BASE	TABLET / ORAL	1988-12-30	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
20231	SUPPL	2009-01-12
20230	SUPPL	2009-01-12
44032	ORIG	2007-03-29
33733	SUPPL	2003-10-10
11497	SUPPL	2003-10-10
11496	SUPPL	2003-10-10
17379	SUPPL	2003-10-09
17378	SUPPL	2003-10-09
1309	SUPPL	2003-10-09
1308	SUPPL	2002-08-29