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Serving leading biopharmaceutical companies globally:

Farmers Insurance
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Generated: October 18, 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 Aurolife Pharma Llc, Vintage, Wockhardt, Warner Chilcott, Whiteworth Town Plsn, Pharm Assoc, Roxane, Everylife, Sandoz, Hi Tech Pharma, Mallinckrodt Inc, Usl Pharma, Duramed Pharms Barr, Teva, Vintage Pharms, Mikart, Lederle, Watson Labs Florida, Halsey, Able, Mutual Pharm, Superpharm, Actavis Mid Atlantic, Puracap Pharm, Kv Pharm, Allied Pharma Inc, Sun Pharm Inds Ltd, Anda Repository, Watson Labs, Vitarine, Am Therap, Amneal Pharms Ny, Purepac Pharm, Valeant Pharm Intl, and Dava Pharms Inc, and is included in ninety-one NDAs. It is available from fifty-six 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-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for NDA: 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 Aurolife Pharma, LLC 13107-058 13107-058-01 100 TABLET in 1 BOTTLE (13107-058-01)
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
TABLET;ORAL 202800 ANDA Aurolife Pharma, LLC 13107-058 13107-058-05 500 TABLET in 1 BOTTLE (13107-058-05)

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:

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