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Generated: April 20, 2019

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Details for New Drug Application (NDA): 085288

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NDA 085288 describes ACETAMINOPHEN AND CODEINE PHOSPHATE, which is a drug marketed by Teva, Aci Healthcare Ltd, Actavis Mid Atlantic, Dava Pharms Inc, Hi Tech Pharma, Lannett Co Inc, Mikart, Pharm Assoc, Wockhardt Bio Ag, Able, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vintage, Vintage Pharms, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, and Whiteworth Town Plsn, and is included in eighty-nine NDAs. It is available from fifty-two 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-three suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for 085288

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG;30MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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