Assyro AI

FDA Orange Book · active-ingredient family

Metoclopramide hydrochloride

Metoclopramide hydrochloride is approved as 6 brand and 59 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:GIMOTI · NDA 209388

6

Brand (NDA)

59

Generics (ANDA)

7

Listed patents

0

Exclusivity periods

Brand (NDA) products · concentrate, injectable, solution, spray, metered, tablet, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
GIMOTIRLDQOL MEDCLNDA 209388—Jun 19, 2020
METOZOLV ODTRLD×2SALIX PHARMSNDA 022246—Sep 04, 2009
REGLANRLD×2ANI PHARMSNDA 017854ABMay 05, 1987
REGLANRLDROBINS AHNDA 018821—Mar 25, 1983
REGLANRLD×2HIKMANDA 017862—Approved Prior to Jan 1, 1982
REGLAN ODT×2MEDA PHARMSNDA 021793—Jun 10, 2005

Generic (ANDA) products (59)

ProductApplicantApplicationTEApproved
METOCLOPRAMIDE HYDROCHLORIDE×2AIPING PHARM INCANDA 072215ABNov 05, 2024
METOCLOPRAMIDE HYDROCHLORIDE×2NOVEL LABS INCANDA 202191—Aug 15, 2014
METOCLOPRAMIDEAVET LIFESCIENCESANDA 204756APDec 20, 2013
METOCLOPRAMIDE HYDROCHLORIDEFRESENIUS KABI USAANDA 091392—Apr 19, 2013
METOCLOPRAMIDE HYDROCHLORIDE×2IPCA LABS LTDANDA 078807ABJun 12, 2008
METOCLOPRAMIDE HYDROCHLORIDE×2NORTHSTAR HLTHCAREANDA 078374—Nov 30, 2007
METOCLOPRAMIDE HYDROCHLORIDE×2STRIDES PHARMA INTLANDA 077878ABAug 28, 2006
METOCLOPRAMIDE HYDROCHLORIDEVISTAPHARM LLCANDA 075051—Jan 26, 2001
METOCLOPRAMIDE HYDROCHLORIDEPHARMOBEDIENT CNSLTGANDA 074703—Oct 31, 1997
METOCLOPRAMIDE HYDROCHLORIDE×2SUN PHARM INDUSTRIESANDA 071536—Jan 16, 1997
METOCLOPRAMIDE HYDROCHLORIDEHOSPIRAANDA 074147—Aug 02, 1996
METOCLOPRAMIDE HYDROCHLORIDE×2IMPAX LABS INCANDA 071250—Dec 28, 1995
METOCLOPRAMIDE HYDROCHLORIDE×2CHARTWELL RXANDA 074478—Oct 05, 1995
METOCLOPRAMIDE HYDROCHLORIDETEVAANDA 071315—Jun 30, 1993
METOCLOPRAMIDE HYDROCHLORIDEANI PHARMSANDA 071402AAJun 25, 1993
METOCLOPRAMIDE HYDROCHLORIDETEVAANDA 072801ABJun 15, 1993
METOCLOPRAMIDE HYDROCHLORIDECHARTWELL MOLECULARANDA 073680—Oct 27, 1992
METOCLOPRAMIDE HYDROCHLORIDEBEDFORDANDA 072247—May 18, 1992
METOCLOPRAMIDE HYDROCHLORIDEBEDFORDANDA 072155—Mar 30, 1992
METOCLOPRAMIDE HYDROCHLORIDEBEDFORDANDA 072244—Mar 30, 1992
METOCLOPRAMIDE INTENSOLROXANEANDA 072995—Jan 30, 1992
METOCLOPRAMIDE HYDROCHLORIDETEVA PHARMS USAANDA 073135APNov 27, 1991
METOCLOPRAMIDE HYDROCHLORIDEPAI HOLDINGSANDA 072744AAMay 28, 1991
METOCLOPRAMIDE HYDROCHLORIDECLONMELANDA 072639—May 09, 1991
METOCLOPRAMIDE HYDROCHLORIDEHOSPIRAANDA 073117—Jan 17, 1991
METOCLOPRAMIDE HYDROCHLORIDEHOSPIRAANDA 073118APJan 17, 1991
METOCLOPRAMIDE HYDROCHLORIDEHOSPIRAANDA 070505—Jun 23, 1989
METOCLOPRAMIDE HYDROCHLORIDEHOSPIRAANDA 070506—Jun 22, 1989
METOCLOPRAMIDE HYDROCHLORIDESANDOZANDA 072436—Jun 22, 1989
METOCLOPRAMIDE HYDROCHLORIDEHOSPIRAANDA 071291—Mar 03, 1989
METOCLOPRAMIDE HYDROCHLORIDEHOSPIRAANDA 071990—Jan 18, 1989
METOCLOPRAMIDE HYDROCHLORIDEPACOANDA 071665—Dec 05, 1988
METOCLOPRAMIDE HYDROCHLORIDEROXANEANDA 072038—Dec 05, 1988
METOCLOPRAMIDE HYDROCHLORIDEHOSPIRAANDA 070847—Nov 07, 1988
METOCLOPRAMIDE HYDROCHLORIDENORBROOKANDA 070892—Aug 26, 1988
METOCLOPRAMIDE HYDROCHLORIDEACTAVIS MID ATLANTICANDA 071340—Aug 18, 1988
CLOPRAQUANTUM PHARMICSANDA 072384—Jun 02, 1988
METOCLOPRAMIDE HYDROCHLORIDETEVAANDA 070819—Jul 10, 1987
METOCLOPRAMIDE HYDROCHLORIDESUPERPHARMANDA 070926—Jun 26, 1987
METOCLOPRAMIDE HYDROCHLORIDEWATSON LABSANDA 070645—May 11, 1987
METOCLOPRAMIDE HYDROCHLORIDEMORTON GROVEANDA 070949—Mar 06, 1987
METOCLOPRAMIDE HYDROCHLORIDESMITH AND NEPHEWANDA 070623—Mar 02, 1987
METOCLOPRAMIDE HYDROCHLORIDESMITH AND NEPHEWANDA 070622—Mar 02, 1987
METOCLOPRAMIDE HYDROCHLORIDEWATSON LABSANDA 070363—Mar 02, 1987
METOCLOPRAMIDE HYDROCHLORIDEMUTUAL PHARMANDA 070660—Feb 10, 1987
METOCLOPRAMIDE HYDROCHLORIDESANDOZANDA 070850—Feb 03, 1987
METOCLOPRAMIDE HYDROCHLORIDESCHERINGANDA 070598—Feb 02, 1987
METOCLOPRAMIDE HYDROCHLORIDEHALSEYANDA 070906—Oct 28, 1986
METOCLOPRAMIDE HYDROCHLORIDEINTERPHARMANDA 071213—Sep 24, 1986
METOCLOPRAMIDE HYDROCHLORIDEWATSON LABSANDA 070453—Jun 06, 1986
METOCLOPRAMIDE HYDROCHLORIDEPAR PHARMANDA 070342—Mar 25, 1986
MAXOLONKING PHARMSANDA 070106—Mar 04, 1986
METOCLOPRAMIDE HYDROCHLORIDELYPHOMEDANDA 070293—Jan 24, 1986
METOCLOPRAMIDE HYDROCHLORIDEWATSON LABSANDA 070511—Jan 22, 1986
"CLOPRA-""YELLOW"""QUANTUM PHARMICSANDA 070632—Oct 28, 1985
METOCLOPRAMIDE HYDROCHLORIDESTRIDES PHARMA INTLANDA 070581—Oct 17, 1985
CLOPRAQUANTUM PHARMICSANDA 070294—Jul 29, 1985
METOCLOPRAMIDE HYDROCHLORIDETEVAANDA 070184ABJul 29, 1985
METOCLOPRAMIDE HYDROCHLORIDEUSL PHARMAANDA 070339—Jul 29, 1985

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11020361Dec 22, 2029in 3 yr 7 mo
U-2843
12194009Dec 22, 2029in 3 yr 7 mo
U-2843
12194008Dec 22, 2029in 3 yr 7 mo
U-2843
11628150Dec 22, 2029in 3 yr 7 mo
ProductU-2843
11813231Dec 22, 2029in 3 yr 7 mo
ProductU-2843
8334281May 16, 2030in 4 yr
ProductU-2843
12377064Nov 17, 2038in 12 yr 7 mo
U-2843

Metoclopramide 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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