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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, Par Pharm, Watson Labs, Organon Usa Inc, Sandoz, Heather, Vintage Pharms, Jubilant Cadista, Duramed Pharms Barr, Akorn, 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 thirty-eight 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 NDA: 087535

Summary for product number 001

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

Summary 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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