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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021756
Company: BAUSCH AND LOMB INC

Products on NDA 021756

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MACUGEN	PEGAPTANIB SODIUM	EQ 0.3MG ACID/0.09ML	INJECTABLE;INTRAVITREAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021756

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2004	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021756lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021756ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-756_Macugen.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2017	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
10/12/2011	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021756s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021756s018ltr.pdf
04/08/2008	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/08/2006	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021756s006,s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021756s006,s007ltr.pdf
03/08/2006	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021756s006,s007lbl.pdf
11/17/2005	SUPPL-5	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021756s004,005ltr.pdf
11/17/2005	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021756s004,005ltr.pdf

Labels for NDA 021756

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/12/2011	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021756s018lbl.pdf
03/08/2006	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021756s006,s007lbl.pdf
03/08/2006	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021756s006,s007lbl.pdf
09/17/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021756lbl.pdf

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