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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 214870


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NDA 214870 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 214870
Pharmacology for NDA: 214870
Suppliers and Packaging for NDA: 214870
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 214870 ANDA Sandoz Inc. 0781-3516 0781-3516-75 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3516-75) / 5 mL in 1 VIAL, MULTI-DOSE
METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 214870 ANDA Sandoz Inc. 0781-3522 0781-3522-70 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-70) / 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/ML
Approval Date:Jan 3, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:May 10, 2023TE:ABRLD:No

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