Viewing data from:

REGLAN

NDA

METOCLOPRAMIDE HYDROCHLORIDE | N018821 | AH ROBINS CO

1 strength0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from International Medication Systems Limited FDA-1987-P-0413 International Medication Systems Limited filed this citizen petition requesting that the FDA determine an abbreviated new drug application is acceptable for Metoclopramide Injection, Reglan®, at a new concentration of 1 mg/mL to replace the currently marketed 5 mg/mL formulation. The petitioner argu	Other	2009-10-22	Denied	International Medication Systems Limited

Source: Regulations.gov. FDA citizen petitions matched by application number.

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

1 letter from Drugs@FDA

Date	Submission	Document
Nov 25, 2002	SUPPL -20	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Mar 25, 1983

No patent or exclusivity listings for this strength.