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METOCLOPRAMIDE HYDROCHLORIDE

ANDA

METOCLOPRAMIDE HYDROCHLORIDE | A202191 | NOVEL LABORATORIES INC

2 strengths0 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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 19, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Aug 15, 2014

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Aug 15, 2014