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Last Updated: June 16, 2021

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Details for New Drug Application (NDA): 011153


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NDA 011153 describes MEDROL, which is a drug marketed by Pharmacia And Upjohn and Pfizer and is included in three NDAs. It is available from five suppliers. Additional details are available on the MEDROL profile page.

The generic ingredient in MEDROL is methylprednisolone. There are forty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the methylprednisolone profile page.
Summary for 011153
Tradename:MEDROL
Applicant:Pfizer
Ingredient:methylprednisolone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 011153
Medical Subject Heading (MeSH) Categories for 011153
Suppliers and Packaging for NDA: 011153
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEDROL methylprednisolone TABLET;ORAL 011153 NDA Pharmacia and Upjohn Company LLC 0009-0020 0009-0020-01 100 TABLET in 1 BOTTLE (0009-0020-01)
MEDROL methylprednisolone TABLET;ORAL 011153 NDA Pharmacia and Upjohn Company LLC 0009-0022 0009-0022-01 25 TABLET in 1 BOTTLE (0009-0022-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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