Last Updated: November 13, 2026

Details for New Drug Application (NDA): 220509

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NDA 220509 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 220509

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1.5MG;5MG
Approval Date:	Sep 22, 2026	TE:	AA	RLD:	No

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