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Generated: June 18, 2019

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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 Abhai Llc, Actavis Mid Atlantic, Hi Tech Pharma, Ivax Sub Teva Pharms, Novel Labs Inc, Paddock Llc, Torrent, and Wockhardt Bio Ag, 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.
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)

Profile 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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