BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Argus Health
Fish and Richardson
Harvard Business School
Federal Trade Commission
Farmers Insurance
US Army

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017854

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NDA 017854 describes REGLAN, which is a drug marketed by West-ward Pharms Int, Robins Ah, Ani Pharms, and Meda Pharms, and is included in four NDAs. It is available from two 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. Forty-five suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for 017854

Formulation / Manufacturing:see details

Pharmacology for NDA: 017854

Mechanism of ActionDopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 017854

Suppliers and Packaging for NDA: 017854

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REGLAN metoclopramide hydrochloride TABLET;ORAL 017854 NDA STAT RX USA LLC 16590-906 16590-906-30 30 TABLET in 1 BOTTLE (16590-906-30)
REGLAN metoclopramide hydrochloride TABLET;ORAL 017854 NDA STAT RX USA LLC 16590-906 16590-906-90 90 TABLET in 1 BOTTLE (16590-906-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:May 5, 1987TE:ABRLD:Yes

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Serving leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Federal Trade Commission
Argus Health

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