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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 four 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-three suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for NDA: 017862

Tradename:
REGLAN
Applicant:
West-ward Pharms Int
Ingredient:
metoclopramide hydrochloride
Patents:0
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
REGLAN
metoclopramide hydrochloride
INJECTABLE;INJECTION 017862 NDA General Injectables & Vaccines, Inc 52584-450 52584-450-39 1 VIAL, SINGLE-DOSE in 1 BAG (52584-450-39) > 2 mL in 1 VIAL, SINGLE-DOSE
REGLAN
metoclopramide hydrochloride
INJECTABLE;INJECTION 017862 NDA General Injectables & Vaccines, Inc 52584-451 52584-451-82 1 VIAL, SINGLE-DOSE in 1 BAG (52584-451-82) > 30 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
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
REGLAN
metoclopramide hydrochloride
INJECTABLE;INJECTION017862-001Approved Prior to Jan 1, 19824,536,386► subscribe
West-ward Pharms Int
REGLAN
metoclopramide hydrochloride
INJECTABLE;INJECTION017862-004May 28, 19874,536,386► subscribe
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