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Last Updated: August 14, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210985

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NDA 210985 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. Nine suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
Summary for 210985
Tradename:METHYLPREDNISOLONE
Applicant:Novast Labs
Ingredient:methylprednisolone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210985
Medical Subject Heading (MeSH) Categories for 210985
Suppliers and Packaging for NDA: 210985
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE methylprednisolone TABLET;ORAL 210985 ANDA Ingenus Pharmaceuticals, LLC 50742-189 50742-189-01 100 TABLET in 1 BOTTLE (50742-189-01)
METHYLPREDNISOLONE methylprednisolone TABLET;ORAL 210985 ANDA Ingenus Pharmaceuticals, LLC 50742-189 50742-189-21 1 BLISTER PACK in 1 CARTON (50742-189-21) > 21 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength4MG
Approval Date:Jan 9, 2019TE:RLD:No

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