Details for New Drug Application (NDA): 215672
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The generic ingredient in PREDNISONE is prednisone. There are sixteen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the prednisone profile page.
Summary for 215672
Tradename: | PREDNISONE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | prednisone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215672
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 215672
Suppliers and Packaging for NDA: 215672
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREDNISONE | prednisone | TABLET;ORAL | 215672 | ANDA | Aurobindo Pharma Limited | 59651-485 | 59651-485-01 | 100 TABLET in 1 BOTTLE (59651-485-01) |
PREDNISONE | prednisone | TABLET;ORAL | 215672 | ANDA | Aurobindo Pharma Limited | 59651-485 | 59651-485-78 | 10 BLISTER PACK in 1 CARTON (59651-485-78) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Mar 28, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 28, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 28, 2022 | TE: | AB | RLD: | No |
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