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Last Updated: June 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088008


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NDA 088008 describes HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, which is a drug marketed by Abhai Llc, Actavis Mid Atlantic, Hi Tech Pharma, Ivax Sub Teva Pharms, Nostrum Labs Inc, Novel Labs Inc, Paddock Llc, Torrent, and Wockhardt Bio Ag, and is included in nine NDAs. It is available from eight 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. Ten suppliers are listed for this compound. Additional details are available on the homatropine methylbromide; hydrocodone bitartrate profile page.
Pharmacology for NDA: 088008
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 088008
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 088008 ANDA Pharmaceutical Associates, Inc. 0121-4811 0121-4811-40 4 TRAY in 1 CASE (0121-4811-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-4811-05)
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE homatropine methylbromide; hydrocodone bitartrate SYRUP;ORAL 088008 ANDA Morton Grove Pharmaceuticals, Inc. 60432-455 60432-455-16 473 mL in 1 BOTTLE, PLASTIC (60432-455-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength1.5MG/5ML;5MG/5ML
Approval Date:Mar 3, 1983TE:AARLD:No

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