Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212262

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NDA 212262 describes METHYLPREDNISOLONE, which is a drug marketed by Elkins Sinn, Organon Usa Inc, Duramed Pharms Barr, Heather, Jubilant Cadista, Lupin Ltd, Novast Labs, Par Pharm, Sandoz, Sungen Pharma, Tianjin Tianyao, Vintage Pharms, Watson Labs, Zydus Pharms, Akorn, Amneal Pharms Co, 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-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. Nine suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.
Summary for 212262
Tradename:METHYLPREDNISOLONE
Applicant:Sungen Pharma
Ingredient:methylprednisolone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212262
Medical Subject Heading (MeSH) Categories for 212262
Suppliers and Packaging for NDA: 212262
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE methylprednisolone TABLET;ORAL 212262 ANDA SunGen Pharma LLC 70625-237 70625-237-01 100 TABLET in 1 BOTTLE (70625-237-01)
METHYLPREDNISOLONE methylprednisolone TABLET;ORAL 212262 ANDA SunGen Pharma LLC 70625-237 70625-237-11 1 DOSE PACK in 1 CARTON (70625-237-11) > 21 TABLET in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Jun 27, 2019TE:ABRLD:No

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