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MECLIZINE HYDROCHLORIDE

ANDA

MECLIZINE HYDROCHLORIDE | A203003 | CHARTWELL RX SCIENCES LLC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ANTIVERT(TE code: AA)

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 (3)

Sort:

#001 — 12.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 11, 2022

No patent or exclusivity listings for this strength.

#002 — 25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 11, 2022

#003 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 11, 2022