Details for New Drug Application (NDA): 212629
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The generic ingredient in PREDNISONE is prednisone. There are sixteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the prednisone profile page.
Summary for 212629
Tradename: | PREDNISONE |
Applicant: | Allied |
Ingredient: | prednisone |
Patents: | 0 |
Pharmacology for NDA: 212629
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 212629
Suppliers and Packaging for NDA: 212629
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREDNISONE | prednisone | TABLET;ORAL | 212629 | ANDA | Granulation Technology, Inc. | 63561-0120 | 63561-0120-1 | 100 TABLET in 1 BOTTLE (63561-0120-1) |
PREDNISONE | prednisone | TABLET;ORAL | 212629 | ANDA | Granulation Technology, Inc. | 63561-0120 | 63561-0120-2 | 1000 TABLET in 1 BOTTLE (63561-0120-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 5, 2023 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 5, 2023 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Dec 5, 2023 | TE: | RLD: | No |
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