Details for New Drug Application (NDA): 040189
✉ Email this page to a colleague
The generic ingredient in METHYLPREDNISOLONE is methylprednisolone acetate. There are forty drug master file entries for this compound. Twelve 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 |
Pharmacology for NDA: 040189
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
Approval Date: | Oct 31, 1997 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | Oct 31, 1997 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 16MG | ||||
Approval Date: | Jul 20, 2007 | TE: | AB | RLD: | No |
Complete Access Available with Subscription