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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087748
Company: ALLERGAN

Products on ANDA 087748

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BLEPHAMIDE S.O.P.	PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM	0.2%;10%	OINTMENT;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087748

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/1986	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
08/15/2001	SUPPL-21	Manufacturing (CMC)-Facility		Label is not available on this site.
08/07/2001	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
08/07/2001	SUPPL-19	Manufacturing (CMC)-Facility		Label is not available on this site.
12/08/2000	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
11/15/1999	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/23/1999	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
11/20/1998	SUPPL-15	Labeling		Label is not available on this site.
06/24/1998	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/27/1998	SUPPL-13	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/27/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/27/1998	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/27/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/31/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/14/1995	SUPPL-8	Labeling		Label is not available on this site.
12/02/1993	SUPPL-7	Labeling		Label is not available on this site.
06/29/1993	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/14/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/15/1991	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/26/1990	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

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