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Generated: October 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091633

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NDA 091633 describes HYDROCODONE BITARTRATE AND IBUPROFEN, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms Ny, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, and Vintage Pharms, and is included in eight NDAs. It is available from fourteen 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-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate; ibuprofen profile page.
Summary for 091633
Pharmacology for NDA: 091633
Suppliers and Packaging for NDA: 091633
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 091633 ANDA Sun Pharmaceutical Industries, Inc. 57664-102 57664-102-08 100 TABLET, FILM COATED in 1 BOTTLE (57664-102-08)
HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 091633 ANDA Sun Pharmaceutical Industries, Inc. 57664-102 57664-102-13 500 TABLET, FILM COATED in 1 BOTTLE (57664-102-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;200MG
Approval Date:May 28, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;200MG
Approval Date:May 28, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG;200MG
Approval Date:May 28, 2013TE:ABRLD:No

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