Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062984
Company: WATSON LABS INC

Products on ANDA 062984

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062984

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/1988	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
04/04/2016	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
12/08/2000	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
05/14/1999	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/29/1998	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/22/1997	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/22/1997	SUPPL-11	Labeling		Label is not available on this site.
02/10/1995	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/27/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/13/1994	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/19/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/19/1993	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/11/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/18/1994	SUPPL-3	Labeling		Label is not available on this site.
11/09/1990	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/07/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.