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Generated: April 30, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017862

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NDA 017862 describes REGLAN, which is a drug marketed by Robins Ah, Ani Pharms, West-ward Pharms Int, and Meda Pharms, and is included in four NDAs. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the REGLAN profile page.

The generic ingredient in REGLAN is metoclopramide hydrochloride. There are twelve drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for NDA: 017862

Formulation / Manufacturing:see details

Pharmacology for NDA: 017862

Mechanism of ActionDopamine D2 Antagonists

Suppliers and Packaging for NDA: 017862

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
metoclopramide hydrochloride
INJECTABLE;INJECTION 017862 NDA Cardinal Health 55154-0452 55154-0452-5 5 VIAL, SINGLE-DOSE in 1 BAG (55154-0452-5) > 2 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 004

Approval Date:May 28, 1987TE:RLD:No

Expired Orange Book Patents for NDA: 017862

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
West-ward Pharms Int
metoclopramide hydrochloride
INJECTABLE;INJECTION017862-001Approved Prior to Jan 1, 19824,536,386► Subscribe
West-ward Pharms Int
metoclopramide hydrochloride
INJECTABLE;INJECTION017862-004May 28, 19874,536,386► Subscribe
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