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. Forty-nine 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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