Drugs@FDA: FDA-Approved Drugs

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

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