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Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040775

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NDA 040775 describes PREDNISOLONE, which is a drug marketed by Hi Tech Pharma Co, Marshall Pharma, Pvt Form, Wockhardt, Watson Labs, Teva Pharms, Phoenix Labs Ny, Nesher Pharms, Vistapharm, West Ward, Elkins Sinn, Purepac Pharm, Barr, Heather, Roxane, Lannett, Vitarine, Valeant Pharm Intl, Everylife, Sandoz, Chartwell Rx, Whiteworth Town Plsn, Inwood Labs, Panray, Sperti, Ferrante, Apotex Inc, Tablicaps, Aurolife Pharma Llc, Vintage, Bundy, Ivax Sub Teva Pharms, Impax Labs, UDL, We Pharms, Superpharm, Teva, Pharm Assoc, Cent Pharms, Akorn, Bel Mar, Vintage Pharms, Alcon Pharms Ltd, Amneal Pharms, Medicis Pharms, Edenbridge Pharms, Bausch And Lomb, Sola Barnes Hind, Mylan Pharms Inc, Hi Tech Pharma, and Mission Pharma, and is included in eighty-two NDAs. It is available from fifteen 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 NDA: 040775

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

Pharmacology for NDA: 040775

Suppliers and Packaging for NDA: 040775

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNISOLONE
prednisolone
SYRUP;ORAL 040775 ANDA Qualitest Pharmaceuticals 0603-1567 0603-1567-56 240 mL in 1 BOTTLE (0603-1567-56)
PREDNISOLONE
prednisolone
SYRUP;ORAL 040775 ANDA Qualitest Pharmaceuticals 0603-1567 0603-1567-58 480 mL in 1 BOTTLE (0603-1567-58)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength15MG/5ML
Approval Date:Sep 21, 2007TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Fuji
Cantor Fitzgerald
Cipla
Baxter
Chubb
Harvard Business School
Boehringer Ingelheim
AstraZeneca
Colorcon
QuintilesIMS

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