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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
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Chinese Patent Office
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Harvard Business School

Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040557

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NDA 040557 describes METHYLPREDNISOLONE ACETATE, which is a drug marketed by Watson Labs, Akorn, Sandoz Inc, and Teva Pharms Usa, and is included in eleven NDAs. It is available from six 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. Fourteen suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.

Summary for NDA: 040557

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

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
INJECTABLE;INJECTION 040557 ANDA Teva Parenteral Medicines, Inc. 0703-0031 0703-0031-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-0031-01) > 1 mL in 1 VIAL, SINGLE-DOSE
methylprednisolone acetate
INJECTABLE;INJECTION 040557 ANDA Teva Parenteral Medicines, Inc. 0703-0031 0703-0031-04 25 VIAL, SINGLE-DOSE in 1 TRAY (0703-0031-04) > 1 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

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

Summary for product number 002

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

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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Argus Health
Express Scripts
US Army

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