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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040401

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NDA 040401 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 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 040401

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: 040401

Suppliers and Packaging for NDA: 040401

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREDNISOLONE prednisolone SYRUP;ORAL 040401 ANDA Apotheca Inc. 12634-686 12634-686-04 120 mL in 1 BOTTLE (12634-686-04)
PREDNISOLONE prednisolone SYRUP;ORAL 040401 ANDA Stat Rx USA 16590-291 16590-291-37 240 mL in 1 BOTTLE (16590-291-37)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength15MG/5ML
Approval Date:Feb 27, 2003TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Medtronic
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Covington
Johnson and Johnson
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Cantor Fitzgerald
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McKinsey
Mallinckrodt
Harvard Business School

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