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Serving leading biopharmaceutical companies globally:

Moodys
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040423

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NDA 040423 describes PREDNISOLONE, which is a drug marketed by Apotex Inc, Hi Tech Pharma Co, Ivax Sub Teva Pharms, Nesher Pharms, Pharm Assoc, Teva Pharms, Vintage, Vistapharm, We Pharms, Wockhardt, Aurolife Pharma Llc, Barr, Bundy, Chartwell Rx, Elkins Sinn, Everylife, Ferrante, Heather, Impax Labs, Inwood Labs, Lannett, Marshall Pharma, Panray, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Roxane, Sandoz, Sperti, Superpharm, Tablicaps, Teva, UDL, Valeant Pharm Intl, Vitarine, Watson Labs, West Ward, Whiteworth Town Plsn, Akorn, Bel Mar, Cent Pharms, Alcon Pharms Ltd, Bausch And Lomb, Sola Barnes Hind, Amneal Pharms, Edenbridge Pharms, Hi Tech Pharma, Medicis Pharms, Mission Pharma, Vintage Pharms, and Mylan Pharms Inc, and is included in eighty-two NDAs. It is available from fourteen suppliers. Additional details are available on the PREDNISOLONE profile page.

The generic ingredient in PREDNISOLONE is prednisolone tebutate. There are eighty-six drug master file entries for this compound. Additional details are available on the prednisolone tebutate profile page.
Summary for 040423
Tradename:PREDNISOLONE
Applicant:Nesher Pharms
Ingredient:prednisolone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040423
Medical Subject Heading (MeSH) Categories for 040423
Suppliers and Packaging for NDA: 040423
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNISOLONE prednisolone SYRUP;ORAL 040423 ANDA Physicians Total Care, Inc. 54868-4748 54868-4748-0 120 mL in 1 BOTTLE (54868-4748-0)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Oct 22, 2001TE:RLD:No

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