Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083764
Company: WATSON LABS

Products on ANDA 083764

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083764

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/13/1974	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
02/19/1999	SUPPL-195	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-194	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/08/1998	SUPPL-193	Manufacturing (CMC)		Label is not available on this site.
01/24/1997	SUPPL-192	Manufacturing (CMC)		Label is not available on this site.
04/15/1991	SUPPL-190	Labeling		Label is not available on this site.
11/08/1989	SUPPL-189	Labeling		Label is not available on this site.
01/11/1991	SUPPL-188	Manufacturing (CMC)		Label is not available on this site.
01/11/1991	SUPPL-187	Manufacturing (CMC)		Label is not available on this site.
12/30/1988	SUPPL-182	Bioequivalence		Label is not available on this site.
06/16/1986	SUPPL-181	Manufacturing (CMC)		Label is not available on this site.
10/31/1984	SUPPL-180	Manufacturing (CMC)		Label is not available on this site.
09/17/1982	SUPPL-179	Manufacturing (CMC)		Label is not available on this site.
05/19/1982	SUPPL-178	Manufacturing (CMC)		Label is not available on this site.
04/05/1982	SUPPL-177	Manufacturing (CMC)		Label is not available on this site.