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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Deloitte
Citi
Farmers Insurance
UBS
Novartis
Merck
Harvard Business School
Cantor Fitzgerald
AstraZeneca

Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040719

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NDA 040719 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. Fifteen suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.

Summary for NDA: 040719

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040719

Suppliers and Packaging for NDA: 040719

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE ACETATE
methylprednisolone acetate
INJECTABLE;INJECTION 040719 ANDA Sandoz Inc 0781-3136 0781-3136-70 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3136-70) > 10 mL in 1 VIAL, MULTI-DOSE
METHYLPREDNISOLONE ACETATE
methylprednisolone acetate
INJECTABLE;INJECTION 040719 ANDA Sandoz Inc 0781-3136 0781-3136-92 10 VIAL, MULTI-DOSE in 1 CARTON (0781-3136-92) > 10 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:Jan 29, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/ML
Approval Date:Jan 29, 2009TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Cipla
Cerilliant
Julphar
Queensland Health
Dow
QuintilesIMS
McKesson
Mallinckrodt
Deloitte
Farmers Insurance

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