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Generated: December 17, 2018

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Details for New Drug Application (NDA): 076642

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NDA 076642 describes REPREXAIN, which is a drug marketed by Amneal Pharms Ny and is included in one NDA. It is available from five suppliers. Additional details are available on the REPREXAIN profile page.

The generic ingredient in REPREXAIN 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 076642
Tradename:REPREXAIN
Applicant:Amneal Pharms Ny
Ingredient:hydrocodone bitartrate; ibuprofen
Patents:0
Pharmacology for NDA: 076642
Suppliers and Packaging for NDA: 076642
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 076642 ANDA Rebel Distributors Corp 21695-268 21695-268-15 15 TABLET in 1 BOTTLE (21695-268-15)
HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 076642 ANDA Rebel Distributors Corp 21695-268 21695-268-28 28 TABLET in 1 BOTTLE (21695-268-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG;200MG
Approval Date:Oct 12, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;200MG
Approval Date:Mar 18, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;200MG
Approval Date:Oct 19, 2007TE:ABRLD:No

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