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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cipla
Teva
Johnson and Johnson
QuintilesIMS
Accenture
McKesson
Daiichi Sankyo
Fish and Richardson

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087006

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NDA 087006 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 forty 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. Forty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for 087006
Tradename:ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:Wockhardt Bio Ag
Ingredient:acetaminophen; codeine phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 087006
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 087006
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate SOLUTION;ORAL 087006 ANDA Morton Grove Pharmaceuticals, Inc. 60432-245 N 60432-245-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength120MG/5ML;12MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Chubb
UBS
US Army
Citi
Medtronic
Baxter
Teva
Healthtrust

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