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Generated: November 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040419

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NDA 040419 describes ACETAMINOPHEN AND CODEINE PHOSPHATE, which is a drug marketed by Aurolife Pharma Llc, Vintage, Wockhardt, Warner Chilcott, Whiteworth Town Plsn, Pharm Assoc, Roxane, Everylife, Sandoz, Hi Tech Pharma, Mallinckrodt Inc, Usl Pharma, Duramed Pharms Barr, Teva, Vintage Pharms, Mikart, Lederle, Watson Labs Florida, Halsey, Able, Mutual Pharm, Superpharm, Actavis Mid Atlantic, Puracap Pharm, Kv Pharm, Allied Pharma Inc, Sun Pharm Inds Ltd, Anda Repository, Watson Labs, Vitarine, Am Therap, Amneal Pharms Ny, Purepac Pharm, Valeant Pharm Intl, and Dava Pharms Inc, and is included in ninety-one NDAs. It is available from fifty-five 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. Fifty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for 040419

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 040419

Mechanism of ActionFull 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 Mallinckrodt, Inc. 0406-0483 0406-0483-01 100 TABLET in 1 BOTTLE (0406-0483-01)
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
TABLET;ORAL 040419 ANDA Mallinckrodt, Inc. 0406-0484 0406-0484-01 100 TABLET in 1 BOTTLE (0406-0484-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;15MG
Approval Date:May 31, 2001TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;30MG
Approval Date:May 31, 2001TE:AARLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;60MG
Approval Date:May 31, 2001TE:AARLD:No


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