Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085738
Company: WATSON LABS

Products on ANDA 085738

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAMETHASONE SODIUM PHOSPHATE	BETAMETHASONE SODIUM PHOSPHATE	EQ 3MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085738

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/1979	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
02/19/1999	SUPPL-23	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-22	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/04/1996	SUPPL-20	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/30/1996	SUPPL-19	Labeling		Label is not available on this site.
05/17/1995	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/18/1992	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/18/1992	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/21/1988	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/21/1988	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/21/1988	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
08/19/1986	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/13/1982	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/22/1982	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.