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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 091528


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NDA 091528 describes HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, which is a drug marketed by Actavis Elizabeth, Avanthi Inc, and Novel Labs Inc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE profile page.

The generic ingredient in HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE is homatropine methylbromide; hydrocodone bitartrate. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the homatropine methylbromide; hydrocodone bitartrate profile page.
Summary for 091528
Tradename:HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
Applicant:Novel Labs Inc
Ingredient:homatropine methylbromide; hydrocodone bitartrate
Patents:0
Pharmacology for NDA: 091528
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 091528
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE homatropine methylbromide; hydrocodone bitartrate TABLET;ORAL 091528 ANDA Novel Laboratories, Inc. 40032-118 40032-118-03 30 TABLET in 1 BOTTLE (40032-118-03)
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE homatropine methylbromide; hydrocodone bitartrate TABLET;ORAL 091528 ANDA Novel Laboratories, Inc. 40032-118 40032-118-24 100 TABLET in 1 BOTTLE (40032-118-24)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1.5MG;5MG
Approval Date:Apr 20, 2011TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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