Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080961
Company: AUROLIFE PHARMA LLC

Products on ANDA 080961

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORPHENIRAMINE MALEATE	CHLORPHENIRAMINE MALEATE	4MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080961

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/1972	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
03/28/1996	SUPPL-79	Manufacturing (CMC)		Label is not available on this site.
01/31/1995	SUPPL-78	Manufacturing (CMC)		Label is not available on this site.
02/21/1989	SUPPL-77	Manufacturing (CMC)		Label is not available on this site.
04/01/1988	SUPPL-76	Manufacturing (CMC)		Label is not available on this site.
04/01/1988	SUPPL-75	Manufacturing (CMC)		Label is not available on this site.
04/01/1988	SUPPL-74	Manufacturing (CMC)		Label is not available on this site.
07/17/1987	SUPPL-73	Manufacturing (CMC)		Label is not available on this site.
09/27/1989	SUPPL-72	Manufacturing (CMC)		Label is not available on this site.
11/01/1988	SUPPL-70	Manufacturing (CMC)		Label is not available on this site.
08/23/1984	SUPPL-68	Manufacturing (CMC)		Label is not available on this site.
08/23/1984	SUPPL-67	Manufacturing (CMC)		Label is not available on this site.
12/14/1983	SUPPL-66	Manufacturing (CMC)		Label is not available on this site.
07/12/1983	SUPPL-64	Manufacturing (CMC)		Label is not available on this site.
02/22/1983	SUPPL-62	Manufacturing (CMC)		Label is not available on this site.
07/06/1982	SUPPL-60	Manufacturing (CMC)		Label is not available on this site.