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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, Par Pharm, Watson Labs, Organon Usa Inc, Sandoz, Heather, Vintage Pharms, Jubilant Cadista, Duramed Pharms Barr, Akorn, Teva Pharms Usa, Bedford Labs, Fresenius Kabi Usa, Intl Medication, Abraxis Pharm, Teva Parenteral, Aurobindo Pharma Ltd, Sagent Pharms, and Hikma Farmaceutica, and is included in fifty-four NDAs. It is available from twenty-four suppliers. Additional details are available on the METHYLPREDNISOLONE profile page.

The generic ingredient in METHYLPREDNISOLONE is methylprednisolone acetate. There are thirty-seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.

Pharmacology for NDA: 040189

Suppliers and Packaging for NDA: 040189

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 040189 ANDA KAISER FOUNDATION HOSPITALS 0179-0124 0179-0124-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0124-70)
TABLET;ORAL 040189 ANDA STAT Rx USA LLC 16590-149 16590-149-21 21 TABLET in 1 BLISTER PACK (16590-149-21)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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