Last Updated: November 8, 2026

Details for New Drug Application (NDA): 021793

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 is one drug master file entry for this compound. Forty 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

Medical Subject Heading (MeSH) Categories for 021793

Antiemetics
Dopamine D2 Receptor Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jun 10, 2005	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jun 10, 2005	TE:		RLD:	No

Expired US Patents for NDA 021793

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005	6,221,392	⤷ Start Trial
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-001	Jun 10, 2005	6,024,981	⤷ Start Trial
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005	6,024,981	⤷ Start Trial
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-001	Jun 10, 2005	6,221,392	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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