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Details for New Drug Application (NDA): 017854

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NDA 017854 describes REGLAN, which is a drug marketed by Robins Ah, Ani Pharms, Eurohlth Intl Sarl, 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-one suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for NDA: 017854

Ani Pharms
metoclopramide hydrochloride

Pharmacology for NDA: 017854

Mechanism of ActionDopamine D2 Antagonists

Suppliers and Packaging for NDA: 017854

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
metoclopramide hydrochloride
TABLET;ORAL 017854 NDA STAT RX USA LLC 16590-906 16590-906-30 30 TABLET in 1 BOTTLE (16590-906-30)
metoclopramide hydrochloride
TABLET;ORAL 017854 NDA STAT RX USA LLC 16590-906 16590-906-60 60 TABLET in 1 BOTTLE (16590-906-60)

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:No

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