Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085740
Company: ANI PHARMS

Products on ANDA 085740

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085740

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/06/1977	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
04/13/1999	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
04/13/1999	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
03/25/1998	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
03/25/1998	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
05/23/1997	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
03/28/1989	SUPPL-23	Bioequivalence		Label is not available on this site.
04/18/1989	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/18/1989	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/18/1989	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
05/09/1988	SUPPL-18	Labeling		Label is not available on this site.
06/24/1987	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/24/1987	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/10/1982	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/10/1982	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/10/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/10/1982	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.