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Serving 500+ biopharmaceutical companies globally:

Julphar
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Generated: August 18, 2017

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 Wockhardt, Hi Tech Pharma, Actavis Mid Atlantic, Paddock Llc, Novel Labs Inc, Bio-pharm Inc, Ivax Sub Teva Pharms, and Abhai Llc, 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 NDA: 088017

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

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)

Summary 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 500+ biopharmaceutical companies globally:

Federal Trade Commission
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Cerilliant

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