Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074128
Company: ACTAVIS MID ATLANTIC

Products on ANDA 074128

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074128

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/1994	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
05/18/2004	SUPPL-16	Labeling		Label is not available on this site.
05/30/2001	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
08/29/2002	SUPPL-13	Labeling		Label is not available on this site.
08/29/2002	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/31/2002	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/31/2002	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/29/2000	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
01/07/1998	SUPPL-8	Labeling		Label is not available on this site.
06/28/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/15/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/15/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/15/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/15/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/07/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/13/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.