Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080336
Company: SANDOZ

Products on ANDA 080336

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080336

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/13/1972	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
01/24/1994	SUPPL-49	Manufacturing (CMC)		Label is not available on this site.
08/03/1989	SUPPL-48	Labeling		Label is not available on this site.
08/11/1987	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
06/15/1987	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
07/30/1986	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
07/30/1986	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
07/30/1986	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
07/30/1986	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
10/01/1984	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
10/01/1984	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
08/23/1984	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
08/23/1984	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
10/12/1982	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
02/26/1982	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
05/17/1982	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.