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Serving leading biopharmaceutical companies globally:

Cipla
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Novartis
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Generated: January 22, 2018

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 Teva, Actavis Mid Atlantic, Allied Pharma Inc, Dava Pharms Inc, Hi Tech Pharma, Mikart, Pharm Assoc, Vintage Pharms, Wockhardt, Able, Am Therap, Amneal Pharms Ny, Anda Repository, Aurolife Pharma Llc, Duramed Pharms Barr, Everylife, Halsey, Kv Pharm, Lederle, Mallinckrodt Inc, Mutual Pharm, Puracap Pharm, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vintage, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, and Whiteworth Town Plsn, and is included in eighty-nine NDAs. It is available from fifty-four 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:ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:Mallinckrodt Inc
Ingredient:acetaminophen; codeine phosphate
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 0406-0484-62 100 TABLET in 1 BLISTER PACK (0406-0484-62)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
Colorcon
Dow
Accenture
Fuji
Express Scripts
Cantor Fitzgerald
Julphar

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