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Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 011757

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NDA 011757 describes DEPO-MEDROL, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from eleven suppliers. Additional details are available on the DEPO-MEDROL profile page.

The generic ingredient in DEPO-MEDROL 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: 011757

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: 011757

Suppliers and Packaging for NDA: 011757

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEPO-MEDROL
methylprednisolone acetate
INJECTABLE;INJECTION 011757 NDA Pharmacia and Upjohn Company LLC 0009-0274 0009-0274-01 1 VIAL, MULTI-DOSE in 1 CARTON (0009-0274-01) > 5 mL in 1 VIAL, MULTI-DOSE
DEPO-MEDROL
methylprednisolone acetate
INJECTABLE;INJECTION 011757 NDA Pharmacia and Upjohn Company LLC 0009-0280 0009-0280-02 1 VIAL, MULTI-DOSE in 1 CARTON (0009-0280-02) > 5 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes


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