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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 040189


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NDA 040189 describes METHYLPREDNISOLONE, which is a drug marketed by Elkins Sinn, Organon Usa Inc, Amneal, Chartwell Rx, Duramed Pharms Barr, Endo Operations, Heather, Invatech, Jubilant Cadista, Novast Labs, Par Pharm, Praxgen, Sandoz, Tianjin Tianyao, Watson Labs, Zydus Pharms, Epic Pharma Llc, Eugia Pharma, Hong Kong, Sagent Pharms Inc, Teva Pharms Usa, Wilshire Pharms Inc, Abraxis Pharm, Bedford Labs, Fresenius Kabi Usa, Hikma, Intl Medication, Teva Parenteral, and Tianjin Kingyork, and is included in sixty-nine NDAs. It is available from twenty-eight suppliers. Additional details are available on the METHYLPREDNISOLONE profile page.

The generic ingredient in METHYLPREDNISOLONE 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 040189
Tradename:METHYLPREDNISOLONE
Applicant:Jubilant Cadista
Ingredient:methylprednisolone
Patents:0
Pharmacology for NDA: 040189
Medical Subject Heading (MeSH) Categories for 040189
Suppliers and Packaging for NDA: 040189
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE methylprednisolone TABLET;ORAL 040189 ANDA Medsource Pharmaceuticals 45865-417 45865-417-21 21 TABLET in 1 BLISTER PACK (45865-417-21)
METHYLPREDNISOLONE methylprednisolone TABLET;ORAL 040189 ANDA A-S Medication Solutions 50090-3094 50090-3094-0 21 TABLET in 1 BLISTER PACK (50090-3094-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Oct 31, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Oct 31, 1997TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG
Approval Date:Jul 20, 2007TE:ABRLD:No

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