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MECLIZINE HYDROCHLORIDE

ANDA

MECLIZINE HYDROCHLORIDE | A084843 | SANDOZ INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ANTIVERT(TE code: AA)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Zydus Pharmaceutical (USA) Inc FDA-2016-P-1667 Zydus Pharmaceuticals (USA) Inc. filed this citizen petition requesting that the FDA determine whether ANTIVERT (Meclizine Hydrochloride) Tablets, 12.5 mg and 25 mg approved under NDA 010721 by Casper Pharma LLC. was voluntarily withdrawn for safety or effectiveness reasons, and if not, to designate	505(q)	2016-06-16	Denied	Zydus Pharmaceutical (USA) Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain10 active DMFs1 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTDMECLIZINE HYDROCHLORIDE

DMF 194192006

JUBILANT PHARMOVA LTDMECLIZINE HYDROCHLORIDE USP

DMF 219872008

COHANCE LIFESCIENCES LTDMECLIZINE HYDROCHLORIDE USP

DMF 223092008

SRIKEM LABORATORIES PRIVATE LTDMECLIZINE HYDROCHLORIDE USP

DMF 229332009

SRI KRISHNA PHARMACEUTICALS LTDMECLIZINE HYDROCHLORIDE USP

DMF 233722009

SYMED LABS LTDMECLIZINE HYDROCHLORIDE

DMF 254182011

THINQ PHARMA-CRO LTDMECLIZINE HYDROCHLORIDE USP

DMF 291612015

CALYX CHEMICALS AND PHARMACEUTICALS LTDMECLIZINE HYDROCHLORIDE

DMF 294172015

R L FINE CHEM PVT LTDMECLIZINE HYDROCHLORIDE

DMF 336612019

RL FINE CHEM PVT LTDMECLIZINE HYDROCHLORIDE

DMF 372892022

UCB PHARMA SAInactiveMECLIZINE HYDROCHLORIDE

DMF 36891980

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#002 — 12.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 22, 1989

No patent or exclusivity listings for this strength.