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Serving 500+ biopharmaceutical companies globally:

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Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083677

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NDA 083677 describes PREDNISONE, which is a drug marketed by Halsey, West-ward Pharms Int, Marshall Pharma, Mutual Pharm, Vangard, Inwood Labs, Vitarine, Phoenix Labs Ny, Contract Pharmacal, Roxane, Elkins Sinn, Jubilant Cadista, Aurolife Pharma Llc, Watson Labs, Whiteworth Town Plsn, Lannett, Nylos, Heather, Wockhardt, Mylan Pharms Inc, Rexall, Ivax Sub Teva Pharms, Kv Pharm, Sandoz, Valeant Pharm Intl, Hikma Pharms, Everylife, Sun Pharm Inds, Panray, Pvt Form, Purepac Pharm, Vintage Pharms, Chartwell Rx, Sperti, Pharmavite, Ferrante, Superpharm, Actavis Labs Fl Inc, Lederle, Upsher Smith, Scherer Labs, Bundy, Impax Labs, UDL, Am Therap, Duramed Pharms Barr, Amneal Pharms Ny, and Teva, and is included in one hundred and seven NDAs. It is available from fifty-seven suppliers. Additional details are available on the PREDNISONE profile page.

The generic ingredient in PREDNISONE is prednisone. There are sixteen drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the prednisone profile page.

Summary for NDA: 083677

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 083677

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNISONE
prednisone
TABLET;ORAL 083677 ANDA West-Ward Pharmaceuticals Corp 0143-9738 0143-9738-01 100 TABLET in 1 BOTTLE (0143-9738-01)
PREDNISONE
prednisone
TABLET;ORAL 083677 ANDA West-Ward Pharmaceuticals Corp 0143-9738 0143-9738-05 500 TABLET in 1 BOTTLE (0143-9738-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

UBS
Accenture
Teva
Merck
Mallinckrodt
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Queensland Health
Healthtrust
US Department of Justice
Harvard Business School

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