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Serving leading biopharmaceutical companies globally:

Dow
Novartis
Julphar
McKesson
Fish and Richardson
Cerilliant
Fuji
Healthtrust
Teva
Moodys

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040119

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NDA 040119 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-six 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-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for NDA: 040119

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

Pharmacology for NDA: 040119

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 040119

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
SOLUTION;ORAL 040119 ANDA Apotheca Inc. 12634-975 12634-975-06 180 mL in 1 BOTTLE (12634-975-06)
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
SOLUTION;ORAL 040119 ANDA Atlantic Biologicals Corps 17856-0079 17856-0079-1 12.5 mL in 1 CUP (17856-0079-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength120MG/5ML;12MG/5ML
Approval Date:Apr 26, 1996TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Merck
Cantor Fitzgerald
Fish and Richardson
Moodys
Harvard Business School
Teva
US Department of Justice
Argus Health
Chubb
Daiichi Sankyo

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