Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086813
Company: WATSON LABS

Products on ANDA 086813

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 086813

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/1979	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
02/20/1998	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
02/20/1998	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
02/20/1998	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
11/02/1994	SUPPL-24	Labeling		Label is not available on this site.
12/23/1993	SUPPL-23	Labeling		Label is not available on this site.
02/05/1991	SUPPL-22	Labeling		Label is not available on this site.
08/19/1987	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
08/01/1986	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
06/10/1983	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
06/10/1983	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/21/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/21/1982	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/21/1982	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/21/1982	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.