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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Julphar
Colorcon
Citi
Boehringer Ingelheim
Chinese Patent Office
QuintilesIMS
Express Scripts
US Army

Generated: June 20, 2018

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, Organon Usa Inc, Duramed Pharms Barr, Heather, Jubilant Cadista, Par Pharm, Sandoz, Tianjin Tianyao, Vintage Pharms, Watson Labs, Zydus Pharms Usa Inc, Akorn, Sandoz Inc, Teva Pharms Usa, Abraxis Pharm, Amneal Pharms Co, Aurobindo Pharma Ltd, Bedford Labs, Fresenius Kabi Usa, Hikma Farmaceutica, Intl Medication, Sagent Pharms, and Teva Parenteral, and is included in fifty-seven NDAs. It is available from twenty-six 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. Fifteen suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
Summary for 088497
Pharmacology for NDA: 088497
Medical Subject Heading (MeSH) Categories for 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 E 54868-2913-0
METHYLPREDNISOLONE methylprednisolone TABLET;ORAL 088497 ANDA Physicians Total Care, Inc. 54868-2913 E 54868-2913-1

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Dow
McKesson
Boehringer Ingelheim
McKinsey
Deloitte
Farmers Insurance
Moodys
Medtronic

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