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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 087996

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NDA 087996 describes MYMETHAZINE FORTIS, which is a drug marketed by Usl Pharma and is included in one NDA. Additional details are available on the MYMETHAZINE FORTIS profile page.

The generic ingredient in MYMETHAZINE FORTIS is promethazine hydrochloride. There are twelve drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.

Summary for 087996

Tradename:	MYMETHAZINE FORTIS
Applicant:	Usl Pharma
Ingredient:	promethazine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 087996

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	25MG/5ML
Approval Date:	Jan 18, 1983	TE:		RLD:	No

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