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Last Updated: March 18, 2024

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, ACI, Actavis Mid Atlantic, Akorn, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Wockhardt Bio Ag, Able, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Wes Pharma Inc, and Whiteworth Town Plsn, and is included in eighty-nine NDAs. It is available from twenty-nine 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for 087006

Profile for product number 001

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

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