Details for New Drug Application (NDA): 084283
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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 084283
Tradename: | PREDNISONE |
Applicant: | Hikma |
Ingredient: | prednisone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 084283
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 084283
Suppliers and Packaging for NDA: 084283
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREDNISONE | prednisone | TABLET;ORAL | 084283 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0019 | 0054-0019-20 | 10 BLISTER PACK in 1 CARTON (0054-0019-20) / 10 TABLET in 1 BLISTER PACK |
PREDNISONE | prednisone | TABLET;ORAL | 084283 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0019 | 0054-0019-25 | 100 TABLET in 1 BOTTLE, PLASTIC (0054-0019-25) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
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