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Generated: May 30, 2017

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Details for New Drug Application (NDA): 040613

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NDA 040613 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 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.

Summary for NDA: 040613

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

Pharmacology for NDA: 040613

Suppliers and Packaging for NDA: 040613

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 040613 ANDA Atlantic Biologicals Corps 17856-0043 17856-0043-1 5 mL in 1 CUP, UNIT-DOSE (17856-0043-1)
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
homatropine methylbromide; hydrocodone bitartrate
SYRUP;ORAL 040613 ANDA Rebel Distributors Corp 21695-869 21695-869-16 473 mL in 1 BOTTLE (21695-869-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength1.5MG/5ML;5MG/5ML
Approval Date:Feb 8, 2008TE:AARLD:No


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