Details for New Drug Application (NDA): 215673
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The generic ingredient in PREDNISOLONE is prednisolone tebutate. There are eighty-eight drug master file entries for this compound. Additional details are available on the prednisolone tebutate profile page.
Summary for 215673
Tradename: | PREDNISOLONE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | prednisolone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215673
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 215673
Suppliers and Packaging for NDA: 215673
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREDNISOLONE | prednisolone | TABLET;ORAL | 215673 | ANDA | Aurobindo Pharma Limited | 59651-491 | 59651-491-01 | 100 TABLET in 1 BOTTLE (59651-491-01) |
PREDNISOLONE | prednisolone | TABLET;ORAL | 215673 | ANDA | Aurobindo Pharma Limited | 59651-491 | 59651-491-50 | 50 TABLET in 1 BOTTLE (59651-491-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 17, 2023 | TE: | AB | RLD: | No |
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