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Last Updated: October 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202800

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NDA 202800 describes ACETAMINOPHEN AND CODEINE PHOSPHATE, which is a drug marketed by Teva, Aci Healthcare Ltd, Actavis Mid Atlantic, Anda Repository, Dava Pharms Inc, Hi Tech Pharma, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, 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, and Whiteworth Town Plsn, and is included in ninety-one NDAs. It is available from thirty-five 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. Thirty-five suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for 202800
Pharmacology for NDA: 202800
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 202800
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 202800 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8102 0615-8102-39 30 TABLET in 1 BLISTER PACK (0615-8102-39)
ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 202800 ANDA Aurolife Pharma, LLC 13107-058 13107-058-01 100 TABLET in 1 BOTTLE (13107-058-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;15MG
Approval Date:Apr 15, 2013TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;30MG
Approval Date:Apr 15, 2013TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;60MG
Approval Date:Apr 15, 2013TE:AARLD:No

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