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Details for New Drug Application (NDA): 206438

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NDA 206438 describes HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE, which is a drug marketed by Tris Pharma Inc and is included in one NDA. It is available from one supplier. Additional details are available on the HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE profile page.

The generic ingredient in HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE is chlorpheniramine maleate; hydrocodone bitartrate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate; hydrocodone bitartrate profile page.

Pharmacology for NDA: 206438

Suppliers and Packaging for NDA: 206438

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
chlorpheniramine maleate; hydrocodone bitartrate
SOLUTION;ORAL 206438 ANDA Tris Pharma Inc 27808-104 27808-104-01 473 mL in 1 BOTTLE (27808-104-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength4MG/5ML;5MG/5ML
Approval Date:Jan 27, 2015TE:AARLD:No

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