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Citi
AstraZeneca
Farmers Insurance
Cerilliant
Deloitte
Federal Trade Commission
Cipla
Boehringer Ingelheim
UBS

Generated: April 20, 2018

DrugPatentWatch Database Preview

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, Bio-pharm Inc, Hi Tech Pharma, Ivax Sub Teva Pharms, Novel Labs Inc, Paddock Llc, and Wockhardt Bio Ag, and is included in eight NDAs. It is available from eleven 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. Fourteen suppliers are listed for this compound. Additional details are available on the homatropine methylbromide; hydrocodone bitartrate profile page.
Summary for 088017
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 N 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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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Merck
Fuji
Queensland Health
Baxter
Accenture
Boehringer Ingelheim
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Medtronic

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