Details for New Drug Application (NDA): 011757

NDA 011757 describes DEPO-MEDROL, which is a drug marketed by Pfizer and is included in one NDA. It is available from three 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. Twelve suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.

Summary for 011757

Tradename:	DEPO-MEDROL
Applicant:	Pfizer
Ingredient:	methylprednisolone acetate
Patents:	0

Pharmacology for NDA: 011757

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

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 & 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 & 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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	40MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	80MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

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