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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 220556


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NDA 220556 describes METHYLPREDNISOLONE ACETATE, which is a drug marketed by Amneal, Caplin, Epic Pharma Llc, Eugia Pharma, Hikma, Hong Kong, Ph Health, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Watson Labs, and Wilshire Pharms Inc, and is included in nineteen NDAs. It is available from nine 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. Eleven suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
Summary for 220556
Tradename:METHYLPREDNISOLONE ACETATE
Applicant:Caplin
Ingredient:methylprednisolone acetate
Patents:0
Pharmacology for NDA: 220556
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 220556
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 220556 ANDA Caplin Steriles Limited 65145-192 65145-192-25 25 VIAL, SINGLE-DOSE in 1 CARTON (65145-192-25) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-192-01)
METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 220556 ANDA Caplin Steriles Limited 65145-193 65145-193-25 25 VIAL, SINGLE-DOSE in 1 CARTON (65145-193-25) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-193-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:Jan 26, 2026TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/ML
Approval Date:Jan 26, 2026TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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