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Generated: November 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040423

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NDA 040423 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 040423

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: 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)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

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Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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