Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084634
Company: MUTUAL PHARM

Products on ANDA 084634

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084634

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/1975	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-55	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-54	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-53	Manufacturing (CMC)		Label is not available on this site.
04/05/1995	SUPPL-52	Labeling		Label is not available on this site.
04/04/1994	SUPPL-51	Labeling		Label is not available on this site.
04/03/1992	SUPPL-50	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-48	Manufacturing (CMC)		Label is not available on this site.
03/27/1991	SUPPL-47	Labeling		Label is not available on this site.
03/31/1987	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
11/19/1985	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
11/19/1985	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
11/19/1985	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
09/30/1982	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
12/07/1981	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.