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Serving leading biopharmaceutical companies globally:

Queensland Health
Cipla
Cantor Fitzgerald
Colorcon
Merck
Fuji
Federal Trade Commission
UBS
Covington
Chinese Patent Office

Generated: October 17, 2017

DrugPatentWatch Database Preview

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 Novel Labs Inc, Avanthi Inc, and Actavis Elizabeth, and is included in three NDAs. It is available from four 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. Fourteen suppliers are listed for this compound. Additional details are available on the homatropine methylbromide; hydrocodone bitartrate profile page.

Summary for NDA: 091528

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

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)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

McKesson
Cipla
Colorcon
Citi
US Department of Justice
Chinese Patent Office
Harvard Business School
Daiichi Sankyo
US Army
Moodys

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