Details for New Drug Application (NDA): 076642

NDA 076642 describes REPREXAIN, which is a drug marketed by Amneal Pharms Ny and is included in one NDA. It is available from one supplier. 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. Three 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

Mechanism of Action

Cyclooxygenase Inhibitors Opioid Agonists

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	Amneal Pharmaceuticals of New York LLC	53746-116	53746-116-01	100 TABLET in 1 BOTTLE (53746-116-01)
HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642	ANDA	Amneal Pharmaceuticals of New York LLC	53746-117	53746-117-01	100 TABLET in 1 BOTTLE (53746-117-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG;200MG
Approval Date:	Oct 12, 2004	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG;200MG
Approval Date:	Mar 18, 2004	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG;200MG
Approval Date:	Oct 19, 2007	TE:		RLD:	No

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