Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084657
Company: ANI PHARMS
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
12/01/1975 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
09/14/2021 SUPPL-54 Labeling-Container/Carton Labels

Label is not available on this site.

03/19/1987 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

08/21/1986 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

08/21/1986 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

09/28/1982 SUPPL-41 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 084657 ANI 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 084657 ANI 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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