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Last Updated: August 4, 2021

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Details for New Drug Application (NDA): 207549


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NDA 207549 describes METHYLPREDNISOLONE SODIUM SUCCINATE, which is a drug marketed by Abraxis Pharm, Amneal, Aurobindo Pharma Ltd, Bedford Labs, Elkins Sinn, Fresenius Kabi Usa, Hikma, Intl Medication, Sagent Pharms Inc, Teva Parenteral, Tianjin Kingyork, and Watson Labs, and is included in thirty-two NDAs. It is available from five 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. Thirteen suppliers are listed for this compound. Additional details are available on the methylprednisolone sodium succinate profile page.
Summary for 207549
Tradename:METHYLPREDNISOLONE SODIUM SUCCINATE
Applicant:Amneal
Ingredient:methylprednisolone sodium succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207549
Suppliers and Packaging for NDA: 207549
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 207549 ANDA Amneal Pharmaceuticals LLC 70121-1000 70121-1000-5 25 VIAL in 1 CARTON (70121-1000-5) > 1 mL in 1 VIAL (70121-1000-1)
METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 207549 ANDA Amneal Pharmaceuticals LLC 70121-1001 70121-1001-5 25 VIAL in 1 CARTON (70121-1001-5) > 2 mL in 1 VIAL (70121-1001-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/VIAL
Approval Date:Nov 9, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 125MG BASE/VIAL
Approval Date:Nov 9, 2016TE:APRLD:No

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