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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205136
Company: INDICUS PHARMA
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
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AA No No
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 50MG 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
02/22/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/10/2020 SUPPL-2 Labeling-Package Insert

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 084657 ANI PHARMS
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AA 087128 APNAR PHARMA LP
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 200432 INVAGEN PHARMS
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 203003 LUPIN LTD
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

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 APNAR PHARMA LP
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 200432 INVAGEN PHARMS
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 203003 LUPIN LTD
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 213957 ZYDUS

TABLET;ORAL; 50MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANTIVERT MECLIZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription Yes AA 010721 CASPER PHARMA LLC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 205136 INDICUS PHARMA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 200432 INVAGEN PHARMS
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AA 203003 LUPIN LTD
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