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Serving 500+ biopharmaceutical companies globally:

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Cantor Fitzgerald
Covington
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Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088497

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NDA 088497 describes METHYLPREDNISOLONE, which is a drug marketed by Elkins Sinn, Par Pharm, Watson Labs, Organon Usa Inc, Sandoz, Heather, Vintage Pharms, Jubilant Cadista, Duramed Pharms Barr, Akorn, Sandoz Inc, Teva Pharms Usa, Bedford Labs, Fresenius Kabi Usa, Intl Medication, Abraxis Pharm, Amneal Pharms Co, Teva Parenteral, Aurobindo Pharma Ltd, Sagent Pharms, and Hikma Farmaceutica, and is included in fifty-five NDAs. It is available from twenty-five suppliers. Additional details are available on the METHYLPREDNISOLONE profile page.

The generic ingredient in METHYLPREDNISOLONE is methylprednisolone acetate. There are forty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.

Summary for NDA: 088497

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: 088497

Suppliers and Packaging for NDA: 088497

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE
methylprednisolone
TABLET;ORAL 088497 ANDA Physicians Total Care, Inc. 54868-2913 54868-2913-0 100 TABLET in 1 BOTTLE, PLASTIC (54868-2913-0)
METHYLPREDNISOLONE
methylprednisolone
TABLET;ORAL 088497 ANDA Physicians Total Care, Inc. 54868-2913 54868-2913-1 30 TABLET in 1 BOTTLE, PLASTIC (54868-2913-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Feb 21, 1984TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Citi
Medtronic
US Army
QuintilesIMS
Moodys
Deloitte
Covington
Cipla
Chinese Patent Office
Johnson and Johnson

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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