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BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

Argus Health
Accenture
Moodys
Medtronic
Baxter
AstraZeneca
Mallinckrodt
Covington
Chubb
Express Scripts

Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085868

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NDA 085868 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, Frontida Biopharm, 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-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 NDA: 085868

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

Pharmacology for NDA: 085868

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 085868

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
TABLET;ORAL 085868 ANDA Sun Pharmaceutical Industries, Inc. 63304-562 63304-562-01 100 TABLET in 1 BOTTLE (63304-562-01)
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
TABLET;ORAL 085868 ANDA Sun Pharmaceutical Industries, Inc. 63304-562 63304-562-05 500 TABLET in 1 BOTTLE (63304-562-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;30MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Argus Health
Mallinckrodt
US Army
Medtronic
Cantor Fitzgerald
McKesson
Baxter
Dow
Daiichi Sankyo
Chinese Patent Office

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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