Assyro AI

FDA Orange Book · active-ingredient family

Meclizine hydrochloride

Meclizine hydrochloride is approved as 1 brand and 37 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ANTIVERT · NDA 010721

1

Brand (NDA)

37

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet, tablet, chewable

ProductApplicantApplicationTEApproved
ANTIVERTRLD×4CASPER PHARMA LLCNDA 010721—Approved Prior to Jan 1, 1982

Generic (ANDA) products (37)

ProductApplicantApplicationTEApproved
MECLIZINE HYDROCHLORIDE×3CHARTWELL RXANDA 203003AAAug 11, 2022
MECLIZINE HYDROCHLORIDEINVAGEN PHARMSANDA 200791—Feb 17, 2022
MECLIZINE HYDROCHLORIDE×3INVAGEN PHARMSANDA 200432—Feb 17, 2022
MECLIZINE HYDROCHLORIDE×2ZYDUS LIFESCIENCESANDA 213957AAJun 23, 2020
MECLIZINE HYDROCHLORIDE×3HERITAGEANDA 205136—Feb 22, 2019
MECLIZINE HYDROCHLORIDE×3AUROBINDO PHARMA USAANDA 202640AASep 17, 2012
MECLIZINE HYDROCHLORIDE×2EPIC PHARMA LLCANDA 200294AAApr 13, 2012
MECLIZINE HYDROCHLORIDE×3AMNEAL PHARMSANDA 201451AAFeb 23, 2011
MECLIZINE HYDROCHLORIDE×2JUBILANT CADISTAANDA 040659AAJun 04, 2010
MECLIZINE HYDROCHLORIDE×2RISINGANDA 040179—Jan 30, 1997
MECLIZINE HYDROCHLORIDESANDOZANDA 084843AAMay 22, 1989
MECLIZINE HYDROCHLORIDESCIEGEN PHARMSANDA 084092AAMay 22, 1989
MECLIZINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 089674—Mar 31, 1988
MECLIZINE HYDROCHLORIDEPLIVAANDA 088733—Dec 11, 1985
MECLIZINE HYDROCHLORIDEANI PHARMSANDA 088732—Dec 11, 1985
MECLIZINE HYDROCHLORIDEPLIVAANDA 088734—Dec 11, 1985
MECLIZINE HYDROCHLORIDESUPERPHARMANDA 089113—Aug 20, 1985
MECLIZINE HYDROCHLORIDESUPERPHARMANDA 089114—Aug 20, 1985
MECLIZINE HYDROCHLORIDEUDLANDA 088256—Jun 13, 1983
MECLIZINE HYDROCHLORIDEUDLANDA 088257—Jun 13, 1983
MECLIZINE HYDROCHLORIDEVANGARDANDA 087877—Apr 20, 1982
MECLIZINE HYDROCHLORIDEVANGARDANDA 087620—Jan 04, 1982
MECLIZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 084976—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDENEXGEN PHARMA INCANDA 086392—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDEABC HOLDINGANDA 085253—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDEABC HOLDINGANDA 085252—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDEANABOLICANDA 085891—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDE×2ANI PHARMSANDA 084657—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDEANI PHARMSANDA 085269—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDEANI PHARMSANDA 085740—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDEBUNDYANDA 084382—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDEBUNDYANDA 084872—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083784—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDEKV PHARMANDA 085524—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDEKV PHARMANDA 085523—Approved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDE×2SENORES PHARMSANDA 087128AAApproved Prior to Jan 1, 1982
MECLIZINE HYDROCHLORIDEWATSON LABSANDA 085195—Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Meclizine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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