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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 207487


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NDA 207487 describes HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, which is a drug marketed by Abhai Llc, Actavis Mid Atlantic, Genus, Ivax Sub Teva Pharms, Nostrum Labs Inc, Novel Labs Inc, Padagis Us, Sciegen Pharms Inc, and Wockhardt Bio Ag, and is included in nine NDAs. It is available from three 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 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.
Pharmacology for NDA: 207487
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 207487
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE homatropine methylbromide; hydrocodone bitartrate SYRUP;ORAL 207487 ANDA KVK-Tech, Inc. 10702-150 10702-150-16 473 mL in 1 BOTTLE (10702-150-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength1.5MG/5ML;5MG/5ML
Approval Date:Feb 21, 2017TE:AARLD:No

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