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Serving leading biopharmaceutical companies globally:

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Cipla
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Merck
Cerilliant
Accenture
Harvard Business School
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Generated: December 11, 2017

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, Actavis Mid Atlantic, Allied Pharma Inc, Dava Pharms Inc, Hi Tech Pharma, Mikart, Pharm Assoc, Vintage Pharms, Wockhardt, Able, Am Therap, Amneal Pharms Ny, Anda Repository, Aurolife Pharma Llc, Duramed Pharms Barr, Everylife, Halsey, Kv Pharm, Lederle, Mallinckrodt Inc, Mutual Pharm, Puracap Pharm, Purepac Pharm, Roxane, Sandoz, 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-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. Fifty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for 202800

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

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 13107-058-30 30 TABLET in 1 BOTTLE (13107-058-30)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Express Scripts
US Army
Mallinckrodt
Federal Trade Commission
Fuji
Novartis
Teva
Citi
Dow
Medtronic

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