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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040581

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NDA 040581 describes PREDNISONE, which is a drug marketed by West-ward Pharms Int, Wockhardt, Actavis Labs Fl Inc, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Bundy, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, Everylife, Ferrante, Halsey, Heather, Hikma Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Jubilant Cadista, Kv Pharm, Lannett, Lederle, Marshall Pharma, Mutual Pharm, Mylan Pharms Inc, Nylos, Panray, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rexall, Roxane, Sandoz, Scherer Labs, Sperti, Sun Pharm Industries, Superpharm, Teva, UDL, Upsher Smith, Valeant Pharm Intl, Vangard, Vintage Pharms, Vitarine, Watson Labs, and Whiteworth Town Plsn, and is included in one hundred and seven NDAs. It is available from fifty-six 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-seven suppliers are listed for this compound. Additional details are available on the prednisone profile page.

Summary for 040581

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

Medical Subject Heading (MeSH) Categories for 040581

Suppliers and Packaging for NDA: 040581

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNISONE prednisone TABLET;ORAL 040581 ANDA Par Pharmaceutical 0603-5336 0603-5336-21 100 TABLET in 1 BOTTLE, PLASTIC (0603-5336-21)
PREDNISONE prednisone TABLET;ORAL 040581 ANDA Department of State Health Services, Pharmacy Branch 55695-013 55695-013-00 100 TABLET in 1 BOTTLE, PLASTIC (55695-013-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Dec 21, 2004TE:ABRLD:No


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