Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086595
Company: MUTUAL PHARM

Products on ANDA 086595

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086595

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/10/1979	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
12/01/1998	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
04/05/1995	SUPPL-32	Labeling		Label is not available on this site.
04/03/1992	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
02/19/1991	SUPPL-28	Labeling		Label is not available on this site.
12/12/1994	SUPPL-27	Labeling		Label is not available on this site.
12/12/1994	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
12/12/1994	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
12/12/1994	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
04/01/1987	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
01/17/1986	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
01/17/1986	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/17/1986	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.