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Express Scripts

Last Updated: November 30, 2023

Details for New Drug Application (NDA): 017854

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NDA 017854 describes REGLAN, which is a drug marketed by Hikma, Robins Ah, Ani Pharms, and Meda Pharms, and is included in four NDAs. It is available from one supplier. Additional details are available on the REGLAN profile page.

The generic ingredient in REGLAN is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 017854
Applicant:Ani Pharms
Ingredient:metoclopramide hydrochloride
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 ANI Pharmaceuticals, Inc. 62559-165 62559-165-01 100 TABLET in 1 BOTTLE, PLASTIC (62559-165-01)
REGLAN metoclopramide hydrochloride TABLET;ORAL 017854 NDA ANI Pharmaceuticals, Inc. 62559-166 62559-166-01 100 TABLET in 1 BOTTLE, PLASTIC (62559-166-01)

Profile for product number 001

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

Profile 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:

Express Scripts
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