Last Updated: November 8, 2026

Details for New Drug Application (NDA): 088017

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NDA 088017 describes HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, which is a drug marketed by Abhai Llc, Actavis Mid Atlantic, Ivax Sub Teva Pharms, Novel Labs Inc, Padagis Us, Pai Holdings, Pharmazone, Pharmobedient, and Sankalp Lifecare, and is included in ten NDAs. It is available from two suppliers. Additional details are available on the HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE profile page.

The generic ingredient in HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE is homatropine methylbromide; hydrocodone bitartrate. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the homatropine methylbromide; hydrocodone bitartrate profile page.

Summary for 088017

Tradename:	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Applicant:	Actavis Mid Atlantic
Ingredient:	homatropine methylbromide; hydrocodone bitartrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	1.5MG/5ML;5MG/5ML
Approval Date:	Jul 5, 1983	TE:	AA	RLD:	No

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