Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050091
Company: ALLERGAN

Products on NDA 050091

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLOROPTIC	CHLORAMPHENICOL	0.5%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050091

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/20/1968	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2002	SUPPL-44	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/2001	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
04/12/2001	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
01/30/2001	SUPPL-40	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50091s40lbl.pdf
10/02/2000	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
10/24/1997	SUPPL-38	Manufacturing (CMC)-Control		Label is not available on this site.
09/09/1997	SUPPL-37	Manufacturing (CMC)-Control		Label is not available on this site.
03/18/1996	SUPPL-36	Manufacturing (CMC)-Control		Label is not available on this site.
07/28/1982	SUPPL-34	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/26/1980	SUPPL-33	Manufacturing (CMC)-Control		Label is not available on this site.
10/31/1979	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
08/27/1979	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
05/22/1979	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
02/18/1977	SUPPL-27	Labeling		Label is not available on this site.
02/15/1977	SUPPL-26	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/28/1976	SUPPL-25	Labeling		Label is not available on this site.
10/13/1976	SUPPL-24	Labeling		Label is not available on this site.
07/20/1976	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
07/02/1976	SUPPL-22	Labeling		Label is not available on this site.
02/03/1976	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
11/21/1975	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
06/26/1975	SUPPL-18	Labeling		Label is not available on this site.
11/26/1974	SUPPL-17	Labeling		Label is not available on this site.
11/14/1974	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/22/1974	SUPPL-15	Labeling		Label is not available on this site.
05/20/1974	SUPPL-14	Labeling		Label is not available on this site.
01/18/1974	SUPPL-13	Labeling		Label is not available on this site.
11/22/1971	SUPPL-12	Labeling		Label is not available on this site.
02/11/1972	SUPPL-11	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
08/03/1995	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
10/03/2000	SUPPL-8	Labeling		Label is not available on this site.
04/05/1989	SUPPL-7	Labeling		Label is not available on this site.
12/02/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/10/1969	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/25/1985	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/25/1985	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/28/1983	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/25/1983	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 050091

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2001	SUPPL-40	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50091s40lbl.pdf