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REGLAN ODT

NDA

METOCLOPRAMIDE HYDROCHLORIDE | N021793 | MEDA PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jun 10, 2005

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jun 10, 2005