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Last Updated: April 21, 2021

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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, Duramed Pharms Barr, Heather, Invatech, Jubilant Cadista, Lupin Ltd, Novast Labs, Par Pharm, Sandoz, Sungen Pharma, Tianjin Tianyao, Vintage Pharms, Watson Labs, Zydus Pharms, Akorn, Amneal, Sagent Pharms Inc, Sandoz Inc, Teva Pharms Usa, Abraxis Pharm, Aurobindo Pharma Ltd, Bedford Labs, Fresenius Kabi Usa, Hikma, Intl Medication, and Teva Parenteral, and is included in sixty-two NDAs. It is available from twenty-seven 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. Seven 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
Formulation / Manufacturing:see details
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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