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Last Updated: August 9, 2020

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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. Additional details are available on the REGLAN ODT profile page.

The generic ingredient in REGLAN ODT is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.
Summary for 021793
Tradename:REGLAN ODT
Applicant:Meda Pharms
Ingredient:metoclopramide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021793

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 5MG BASE
Approval Date:Jun 10, 2005TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrengthEQ 10MG BASE
Approval Date:Jun 10, 2005TE:RLD:No

Expired US Patents for NDA 021793

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-001 Jun 10, 2005   Start Trial   Start Trial
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-002 Jun 10, 2005   Start Trial   Start Trial
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-002 Jun 10, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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