Application 021756

Type: NDA
Sponsor: VALEANT PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MACUGEN	PEGAPTANIB SODIUM	INJECTABLE;INTRAVITREAL	EQ 0.3MG ACID/0.09ML	Yes	Yes

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
N021756-001	MACUGEN	PEGAPTANIB SODIUM	EQ 0.3MG ACID/0.09ML	INJECTABLE / INTRAVITREAL		RLD	2004-12-17

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	N021756-001	MACUGEN	EQ 0.3MG ACID/0.09ML	INJECTABLE / INTRAVITREAL	RLD	2004-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021756-001	MACUGEN	EQ 0.3MG ACID/0.09ML	INJECTABLE / INTRAVITREAL	RLD	2004-12-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021756-001	MACUGEN	EQ 0.3MG ACID/0.09ML	INJECTABLE / INTRAVITREAL	RLD	2004-12-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021756-001	MACUGEN	EQ 0.3MG ACID/0.09ML	INJECTABLE / INTRAVITREAL	RLD	2004-12-17	`a50c72e98297…`

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68782-001	Macugen	pegaptanib sodium	Bausch & Lomb Incorporated	NDA	Current
68782-001	Macugen	pegaptanib sodium	Bausch Health US, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
16317	SUPPL	2011-10-20
28530	SUPPL	2011-10-14
28529	SUPPL	2006-03-23
37589	SUPPL	2006-03-10
16316	SUPPL	2006-03-10
6128	SUPPL	2005-11-18
6127	SUPPL	2005-11-18
21806	ORIG	2005-03-28
16315	ORIG	2004-12-30
6126	ORIG	2004-12-30