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Serving leading biopharmaceutical companies globally:

Cerilliant
Cipla
Express Scripts
Dow
Harvard Business School
US Department of Justice
Citi
Colorcon
Fuji
Johnson and Johnson

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089673

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NDA 089673 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 Bio Ag, Able, Am Therap, Amneal Pharms Ny, Anda Repository, Aurolife Pharma Llc, Duramed Pharms Barr, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mutual Pharm, Puracap Pharm, Purepac Pharm, Roxane, Sandoz, Specgx Llc, 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-three 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-five suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for 089673
Tradename:ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:Anda Repository
Ingredient:acetaminophen; codeine phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089673
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 089673
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 089673 ANDA Mutual Pharmaceutical Company, Inc. 53489-161 E 53489-161-02
ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 089673 ANDA Mutual Pharmaceutical Company, Inc. 53489-161 E 53489-161-10

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG;60MG
Approval Date:Feb 10, 1988TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG;15MG
Approval Date:Feb 10, 1988TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG;30MG
Approval Date:Feb 10, 1988TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Accenture
Teva
UBS
Boehringer Ingelheim
Colorcon
Moodys
Daiichi Sankyo

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