Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087128
Company: ANNORA PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AA No No
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
06/03/1981 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
12/28/2012 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

10/05/1998 SUPPL-21 Labeling

Label is not available on this site.

02/18/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/24/1988 SUPPL-17 Labeling

Label is not available on this site.

07/16/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/16/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/16/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/16/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/16/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/27/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/27/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/27/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/15/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

MECLIZINE HYDROCHLORIDE

TABLET;ORAL; 25MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANTIVERT MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription Yes AA 010721 CASPER PHARMA LLC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 201451 AMNEAL PHARMS
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 087128 ANNORA PHARMA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 200294 EPIC PHARMA LLC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 205136 INDICUS PHARMA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 084092 INVATECH
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 040659 JUBILANT CADISTA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 213957 ZYDUS

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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