Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084843
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription AA 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
02/03/1976 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
05/15/2002 SUPPL-98 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/2002 SUPPL-97 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/2001 SUPPL-96 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-91 Labeling

Label is not available on this site.

11/07/1995 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

02/07/1996 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

05/22/1989 SUPPL-85 Labeling

Label is not available on this site.

03/21/1986 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

07/05/1985 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

03/01/1985 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

04/12/1984 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

04/12/1984 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

01/25/1984 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

MECLIZINE HYDROCHLORIDE

TABLET;ORAL; 12.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANTIVERT MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription Yes AA 010721 CASPER PHARMA LLC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 201451 AMNEAL PHARMS
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 087128 ANNORA PHARMA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 200294 EPIC PHARMA LLC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 205136 INDICUS PHARMA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 040659 JUBILANT CADISTA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 084843 SANDOZ
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 213957 ZYDUS

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