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Last Updated: August 14, 2020

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Details for New Drug Application (NDA): 040232

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NDA 040232 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 040232
Applicant:Watson Labs
Formulation / Manufacturing:see details
Pharmacology for NDA: 040232
Medical Subject Heading (MeSH) Categories for 040232
Suppliers and Packaging for NDA: 040232
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPREDNISOLONE methylprednisolone TABLET;ORAL 040232 ANDA Actavis Pharma, Inc. 0591-0790 0591-0790-01 100 TABLET in 1 BOTTLE (0591-0790-01)
METHYLPREDNISOLONE methylprednisolone TABLET;ORAL 040232 ANDA Actavis Pharma, Inc. 0591-0790 0591-0790-21 21 TABLET in 1 BLISTER PACK (0591-0790-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Oct 16, 1997TE:ABRLD:No

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Boehringer Ingelheim

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