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Last Updated: April 21, 2021

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Details for New Drug Application (NDA): 089207

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NDA 089207 describes METHYLPREDNISOLONE, which is a drug marketed by Elkins Sinn, Organon Usa Inc, Duramed Pharms Barr, Heather, Invatech, Jubilant Cadista, Lupin Ltd, Novast Labs, Par Pharm, Sandoz, Sungen Pharma, Tianjin Tianyao, Vintage Pharms, Watson Labs, Zydus Pharms, Akorn, Amneal, Sagent Pharms Inc, Sandoz Inc, Teva Pharms Usa, Abraxis Pharm, Aurobindo Pharma Ltd, Bedford Labs, Fresenius Kabi Usa, Hikma, Intl Medication, and Teva Parenteral, and is included in sixty-two NDAs. It is available from twenty-seven 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. Seven suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
Summary for 089207
Tradename:METHYLPREDNISOLONE
Applicant:Par Pharm
Ingredient:methylprednisolone
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 089207

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength16MG
Approval Date:Apr 25, 1988TE:RLD:No

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Serving leading biopharmaceutical companies globally:

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