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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 084901

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NDA 084901 describes PROMETHACON, which is a drug marketed by Polymedica and is included in two NDAs. Additional details are available on the PROMETHACON profile page.

The generic ingredient in PROMETHACON is promethazine hydrochloride. There are twelve drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.

Summary for 084901

Tradename:	PROMETHACON
Applicant:	Polymedica
Ingredient:	promethazine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 084901

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUPPOSITORY;RECTAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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