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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 212418

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NDA 212418 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 212418

Tradename:	ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:	Elite Labs Inc
Ingredient:	acetaminophen; codeine phosphate
Patents:	0

Pharmacology for NDA: 212418

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 212418

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	212418	ANDA	Elite Laboratories, Inc.	64850-641	64850-641-01	100 TABLET in 1 BOTTLE (64850-641-01)
ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	212418	ANDA	Elite Laboratories, Inc.	64850-641	64850-641-12	120 TABLET in 1 BOTTLE (64850-641-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;15MG
Approval Date:	Sep 10, 2019	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;30MG
Approval Date:	Sep 10, 2019	TE:	AA	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;60MG
Approval Date:	Sep 10, 2019	TE:	AA	RLD:	No

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