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Details for New Drug Application (NDA): 021793

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NDA 021793 describes REGLAN ODT, which is a drug marketed by Meda Pharms and is included in one NDA. There are two patents protecting this drug. Additional details are available on the REGLAN ODT profile page.

The generic ingredient in REGLAN ODT is metoclopramide hydrochloride. There are twelve drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for NDA: 021793

Tradename:
REGLAN ODT
Applicant:
Meda Pharms
Ingredient:
metoclopramide hydrochloride
Patents:2
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 5MG BASE
Approval Date:Jun 10, 2005TE:RLD:No
Patent:6,024,981Patent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:6,221,392Patent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE
Approval Date:Jun 10, 2005TE:RLD:No
Patent:6,024,981Patent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?


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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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