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Details for New Drug Application (NDA): 077723

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NDA 077723 describes HYDROCODONE BITARTRATE AND IBUPROFEN, which is a drug marketed by Actavis Labs Fl Inc, Teva, Vintage Pharms, Sun Pharm Inds Inc, Amneal Pharms Ny, and Aurolife Pharma Llc, and is included in eight NDAs. It is available from twenty-three suppliers. Additional details are available on the HYDROCODONE BITARTRATE AND IBUPROFEN profile page.

The generic ingredient in HYDROCODONE BITARTRATE AND IBUPROFEN is hydrocodone bitartrate; ibuprofen. There are twenty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate; ibuprofen profile page.

Summary for NDA: 077723

Pharmacology for NDA: 077723

Suppliers and Packaging for NDA: 077723

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydrocodone bitartrate; ibuprofen
TABLET;ORAL 077723 ANDA Qualitest Pharmaceuticals 0603-3586 0603-3586-21 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3586-21)
hydrocodone bitartrate; ibuprofen
TABLET;ORAL 077723 ANDA Qualitest Pharmaceuticals 0603-3897 0603-3897-21 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3897-21)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG;200MG
Approval Date:Nov 6, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;200MG
Approval Date:Nov 6, 2006TE:ABRLD:No

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