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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 207667


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NDA 207667 describes METHYLPREDNISOLONE SODIUM SUCCINATE, which is a drug marketed by Abraxis Pharm, Amneal, Bedford Labs, Elkins Sinn, Eugia Pharma, Fresenius Kabi Usa, Hikma, Intl Medication, Sagent Pharms Inc, Teva Parenteral, Tianjin Kingyork, and Watson Labs, and is included in thirty-three NDAs. It is available from seven 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 207667
Tradename:METHYLPREDNISOLONE SODIUM SUCCINATE
Applicant:Eugia Pharma
Ingredient:methylprednisolone sodium succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207667
Suppliers and Packaging for NDA: 207667
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 207667 ANDA AuroMedics Pharma LLC 55150-262 55150-262-03 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-262-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 207667 ANDA AuroMedics Pharma LLC 55150-263 55150-263-03 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-263-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/VIAL
Approval Date:Dec 15, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 125MG BASE/VIAL
Approval Date:Dec 15, 2015TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Dec 15, 2015TE:RLD:No

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