Details for New Drug Application (NDA): 088703
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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 088703
Tradename: | PREDNISONE |
Applicant: | Hikma |
Ingredient: | prednisone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 088703
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 088703
Suppliers and Packaging for NDA: 088703
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREDNISONE | prednisone | SOLUTION;ORAL | 088703 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3722 | 0054-3722-50 | 120 mL in 1 BOTTLE (0054-3722-50) |
PREDNISONE | prednisone | SOLUTION;ORAL | 088703 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3722 | 0054-3722-63 | 500 mL in 1 BOTTLE (0054-3722-63) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Nov 8, 1984 | TE: | RLD: | Yes |
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