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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 040419

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NDA 040419 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 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 suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for 040419

Tradename:	ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:	Specgx Llc
Ingredient:	acetaminophen; codeine phosphate
Patents:	0

Pharmacology for NDA: 040419

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 040419

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	040419	ANDA	SpecGx LLC	0406-0483	0406-0483-01	100 TABLET in 1 BOTTLE (0406-0483-01)
ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	040419	ANDA	SpecGx LLC	0406-0484	0406-0484-01	100 TABLET in 1 BOTTLE (0406-0484-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;15MG
Approval Date:	May 31, 2001	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;30MG
Approval Date:	May 31, 2001	TE:	AA	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;60MG
Approval Date:	May 31, 2001	TE:	AA	RLD:	No

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