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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 040557


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NDA 040557 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 040557
Tradename:METHYLPREDNISOLONE ACETATE
Applicant:Hong Kong
Ingredient:methylprednisolone acetate
Patents:0
Pharmacology for NDA: 040557
Suppliers and Packaging for NDA: 040557
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 040557 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1429 51662-1429-1 1 mL in 1 VIAL, SINGLE-DOSE (51662-1429-1)
METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 040557 ANDA Proficient Rx LP 63187-474 63187-474-01 1 VIAL, SINGLE-DOSE in 1 CARTON (63187-474-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:Feb 23, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/ML
Approval Date:Feb 23, 2005TE:ABRLD:No

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