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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 201835


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NDA 201835 describes METHYLPREDNISOLONE ACETATE, which is a drug marketed by Amneal, Endo Operations, Epic Pharma Llc, Eugia Pharma, Hong Kong, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Watson Labs, and Wilshire Pharms Inc, and is included in seventeen NDAs. It is available from ten suppliers. Additional details are available on the METHYLPREDNISOLONE ACETATE profile page.

The generic ingredient in METHYLPREDNISOLONE ACETATE is methylprednisolone acetate. There are forty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
Summary for 201835
Pharmacology for NDA: 201835
Suppliers and Packaging for NDA: 201835
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 201835 ANDA Sagent Pharmaceuticals 25021-820 25021-820-05 1 VIAL in 1 CARTON (25021-820-05) / 5 mL in 1 VIAL
METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 201835 ANDA Sagent Pharmaceuticals 25021-820 25021-820-10 1 VIAL in 1 CARTON (25021-820-10) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Jun 27, 2018TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:Jun 27, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/ML
Approval Date:Jun 27, 2018TE:ABRLD:No

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