Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086833
Company: ACTAVIS MID ATLANTIC

Products on ANDA 086833

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SYRUP;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086833

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/1980	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
10/02/2000	SUPPL-27	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/29/1997	SUPPL-25	Labeling		Label is not available on this site.
09/28/1990	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
04/05/1990	SUPPL-22	Labeling		Label is not available on this site.
12/26/1989	SUPPL-21	Labeling		Label is not available on this site.
10/11/1989	SUPPL-20	Labeling		Label is not available on this site.
03/03/1989	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
03/03/1989	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/03/1989	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
11/06/1989	SUPPL-16	Labeling		Label is not available on this site.
11/05/1986	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/11/1983	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/26/1982	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
11/22/1982	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.