Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050081
Company: ALLERGAN

Products on NDA 050081

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POLY-PRED	NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE	EQ 0.35% BASE;10,000 UNITS/ML;0.5%	SUSPENSION/DROPS;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050081

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/1963	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2003	SUPPL-38	Labeling		Label is not available on this site.
04/12/2002	SUPPL-36	Manufacturing (CMC)-Control		Label is not available on this site.
02/21/2002	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
04/12/2001	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
10/02/2000	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
05/19/1998	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
08/02/1982	SUPPL-29	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/30/1981	SUPPL-28	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/18/1980	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
11/16/1979	SUPPL-24	Labeling		Label is not available on this site.
12/02/1965	SUPPL-18	Labeling		Label is not available on this site.
08/03/1995	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
03/07/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/17/1987	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
06/23/1964	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/12/1985	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/04/1985	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/23/1963	SUPPL-7	Labeling		Label is not available on this site.
02/10/1984	SUPPL-6	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
11/01/1985	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/18/1983	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/1984	SUPPL-3	Labeling		Label is not available on this site.
10/26/1982	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.