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Last Updated: January 17, 2020

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Acetaminophen; codeine phosphate - Generic Drug Details

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What are the generic drug sources for acetaminophen; codeine phosphate and what is the scope of freedom to operate?

Acetaminophen; codeine phosphate is the generic ingredient in seventeen branded drugs marketed by Teva, Robins Ah, Solvay, Ortho Mcneil Pharm, Aci Healthcare Ltd, Actavis Mid Atlantic, Anda Repository, Dava Pharms Inc, Hi Tech Pharma, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, Valeant Pharms Llc, Able, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Eywa, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, 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, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, and Janssen Pharms, and is included in one hundred and ten NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for acetaminophen; codeine phosphate. Thirty-four suppliers are listed for this compound.

Summary for acetaminophen; codeine phosphate
Recent Clinical Trials for acetaminophen; codeine phosphate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Roxane LaboratoriesPhase 1

See all acetaminophen; codeine phosphate clinical trials

Pharmacology for acetaminophen; codeine phosphate
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Synonyms for acetaminophen; codeine phosphate
C18H21NO3.C8H9NO2.H3O4P
LS-178487
SCHEMBL218798

US Patents and Regulatory Information for acetaminophen; codeine phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 085964-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Halsey ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 083871-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Kv Pharm ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 085365-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Vangard PAPA-DEINE #3 acetaminophen; codeine phosphate TABLET;ORAL 088037-001 Mar 20, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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