Details for New Drug Application (NDA): 215246
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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 215246
Tradename: | PREDNISONE |
Applicant: | Novitium Pharma |
Ingredient: | prednisone |
Patents: | 0 |
Pharmacology for NDA: 215246
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 215246
Suppliers and Packaging for NDA: 215246
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREDNISONE | prednisone | TABLET;ORAL | 215246 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-774 | 10135-774-01 | 100 TABLET in 1 BOTTLE (10135-774-01) |
PREDNISONE | prednisone | TABLET;ORAL | 215246 | ANDA | ANI Pharmaceuticals, Inc. | 70954-056 | 70954-056-10 | 100 TABLET in 1 BOTTLE (70954-056-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Jul 6, 2021 | TE: | AB | RLD: | No |
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