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Last Updated: December 13, 2019

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Details for New Drug Application (NDA): 087535

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NDA 087535 describes METHYLPREDNISOLONE, which is a drug marketed by Elkins Sinn, Organon Usa Inc, Duramed Pharms Barr, Heather, Jubilant Cadista, Lupin Ltd, Novast Labs, Par Pharm, Sandoz, Sungen Pharma, Tianjin Tianyao, Vintage Pharms, Watson Labs, Zydus Pharms, Akorn, Amneal Pharms Co, 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-eight 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. Nine suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
Summary for 087535
Tradename:METHYLPREDNISOLONE
Applicant:Organon Usa Inc
Ingredient:methylprednisolone sodium succinate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 25, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Jun 25, 1982TE:RLD:No

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