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Generated: June 20, 2019

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Details for New Drug Application (NDA): 040641

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NDA 040641 describes METHYLPREDNISOLONE SODIUM SUCCINATE, which is a drug marketed by Abraxis Pharm, Amneal Pharms Co, Aurobindo Pharma Ltd, Bedford Labs, Elkins Sinn, Fresenius Kabi Usa, Hikma Farmaceutica, Intl Medication, Sagent Pharms, Teva Parenteral, and Watson Labs, and is included in thirty-one NDAs. It is available from six suppliers. Additional details are available on the METHYLPREDNISOLONE SODIUM SUCCINATE profile page.

The generic ingredient in METHYLPREDNISOLONE SODIUM SUCCINATE is methylprednisolone sodium succinate. There are forty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the methylprednisolone sodium succinate profile page.
Summary for 040641
Tradename:METHYLPREDNISOLONE SODIUM SUCCINATE
Applicant:Bedford Labs
Ingredient:methylprednisolone sodium succinate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 125MG BASE/VIAL
Approval Date:Feb 21, 2007TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Feb 21, 2007TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Feb 21, 2007TE:RLD:No

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