Last Updated: November 9, 2026

Details for New Drug Application (NDA): 080977

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NDA 080977 describes PROPANTHELINE BROMIDE, which is a drug marketed by Ascot, Heather, Hikma, Impax Labs, Mylan, Par Pharm, Pvt Form, Sandoz, Tablicaps, and Watson Labs, and is included in eleven NDAs. Additional details are available on the PROPANTHELINE BROMIDE profile page.

The generic ingredient in PROPANTHELINE BROMIDE is propantheline bromide. There is one drug master file entry for this compound. Additional details are available on the propantheline bromide profile page.

Summary for 080977

Tradename:	PROPANTHELINE BROMIDE
Applicant:	Pvt Form
Ingredient:	propantheline bromide
Patents:	0

Medical Subject Heading (MeSH) Categories for 080977

Anti-Ulcer Agents
Muscarinic Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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