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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 214297


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NDA 214297 describes METHYLPREDNISOLONE ACETATE, which is a drug marketed by Amneal, Epic Pharma Llc, Eugia Pharma, Hong Kong, Par Sterile Products, Sagent Pharms Inc, Sandoz, Slayback Pharma Llc, Teva Pharms Usa, and Watson Labs, and is included in seventeen 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 214297
Tradename:METHYLPREDNISOLONE ACETATE
Applicant:Par Sterile Products
Ingredient:methylprednisolone acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 214297
Suppliers and Packaging for NDA: 214297
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 214297 ANDA Par Pharmaceutical, Inc. 42023-238 42023-238-01 1 VIAL in 1 CARTON (42023-238-01) / 5 mL in 1 VIAL
METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 214297 ANDA Par Pharmaceutical, Inc. 42023-239 42023-239-01 1 VIAL in 1 CARTON (42023-239-01) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:Jan 21, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/ML
Approval Date:Jan 21, 2022TE:ABRLD:No

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