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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 085868

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NDA 085868 describes ACETAMINOPHEN AND CODEINE PHOSPHATE, which is a drug marketed by Teva, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Pai Holdings, Strides Pharma, Wockhardt Bio Ag, Able, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Wes Pharma Inc, and Whiteworth Town Plsn, and is included in eighty-nine NDAs. It is available from thirty-one suppliers. Additional details are available on the ACETAMINOPHEN AND CODEINE PHOSPHATE profile page.

The generic ingredient in ACETAMINOPHEN AND CODEINE PHOSPHATE is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for 085868

Tradename:	ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	acetaminophen; codeine phosphate
Patents:	0

Pharmacology for NDA: 085868

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 085868

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	085868	ANDA	Sun Pharmaceutical Industries, Inc.	63304-562	63304-562-01	100 TABLET in 1 BOTTLE (63304-562-01)
ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	085868	ANDA	Sun Pharmaceutical Industries, Inc.	63304-562	63304-562-05	500 TABLET in 1 BOTTLE (63304-562-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG;30MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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