Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086096
Company: WATSON LABS

Products on ANDA 086096

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORPHENIRAMINE MALEATE	CHLORPHENIRAMINE MALEATE	10MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086096

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/09/1979	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-36	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-35	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/04/1996	SUPPL-34	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/13/1991	SUPPL-32	Labeling		Label is not available on this site.
05/03/1990	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
02/28/1989	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
02/28/1989	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
02/28/1989	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
05/01/1986	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
07/29/1986	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
07/12/1985	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
04/08/1996	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
05/17/1983	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.