Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022211
Company: BAUSCH AND LOMB

• Summary Review

Products on NDA 022211

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZIRGAN	GANCICLOVIR	0.15%	GEL;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022211

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2009	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022211lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022211s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022211_zirgan_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022211s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2014	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/29/2014	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/26/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022211

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022211lbl.pdf