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Generated: June 25, 2019

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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, Breckenridge Pharm, Hi Tech Pharma, Ivax Sub Teva Pharms, Novel Labs Inc, Paddock Llc, Torrent, and Wockhardt Bio Ag, and is included in nine NDAs. It is available from ten 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. Thirteen suppliers are listed for this compound. Additional details are available on the homatropine methylbromide; hydrocodone bitartrate profile page.
Pharmacology for NDA: 088017
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 088017
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 088017 ANDA Actavis Pharma, Inc. 0472-1030 0472-1030-16 473 mL in 1 BOTTLE (0472-1030-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength1.5MG/5ML;5MG/5ML
Approval Date:Jul 5, 1983TE:AARLD:No

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