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Generated: June 29, 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. Forty-eight suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for NDA: 017862

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 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

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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Serving 500+ biopharmaceutical companies globally:

Medtronic
Merck
Express Scripts
Deloitte
Baxter
QuintilesIMS
Harvard Business School
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AstraZeneca
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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