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METOCLOPRAMIDE HYDROCHLORIDE

ANDA

METOCLOPRAMIDE HYDROCHLORIDE | A072744 | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA

1 strength0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs5 inactive

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

COSMA SPAMETOCLOPRAMIDE HYDROCHLORIDE

DMF 45231982

LIAOYUAN SILVER EAGLE PHARMACEUTICAL CO LTDMETOCLOPRAMIDE HYDROCHLORIDE

DMF 289872014

EMCURE PHARMACEUTICALS LTDMETOCLOPRAMIDE HYDROCHLORIDE USP

DMF 329912018

DINAMITE DIPHARMA SPAInactiveMETOCLOPRAMIDE HYDROCHLORIDE BP'80

DMF 43811981

ORGAMOL SAInactiveMETOCLOPRAMIDE

DMF 58131985

BOEHRINGER INGELHEIM CHEMICALS INCInactiveMETOCLOPRAMIDE

DMF 60701985

MEDICHEM SAInactiveMETOCLOPRAMIDE HYDROCHLORIDE

DMF 62391986

BENZOCHEM LIFESCIENCES PVT LTDInactiveMETOCLOPRAMIDE HYDROCHLORIDE USP

DMF 212712008

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

Products (1)

#001 — EQ 5MG BASE/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: May 28, 1991

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

PAI Holdings became the applicant for metoclopramide hydrochloride NDA 072744 following a change from Genus.

Old: GENUS

New: PAI HOLDINGS

MODIFIEDApplicant Full Name7/1/2026

PAI Holdings LLC acquired the NDA for metoclopramide hydrochloride (A072744-001) from Genus Lifesciences Inc, as reflected in the applicant name change in the FDA Orange Book.

Old: GENUS LIFESCIENCES INC

New: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA