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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088627

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NDA 088627 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 088627
Tradename:ACETAMINOPHEN AND CODEINE PHOSPHATE
Applicant:Teva
Ingredient:acetaminophen; codeine phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 088627
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 088627
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 088627 ANDA Teva Pharmaceuticals USA, Inc. 0093-0050 N 0093-0050-01
ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 088627 ANDA EPM Packaging Inc 61502-903 N 61502-903-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;15MG
Approval Date:Mar 6, 1985TE:AARLD:No

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