Details for New Drug Application (NDA): 088810
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NDA 088810 describes PREDNISONE INTENSOL, which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. Additional details are available on the PREDNISONE INTENSOL profile page.
The generic ingredient in PREDNISONE INTENSOL is prednisone. There are sixteen drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the prednisone profile page.
The generic ingredient in PREDNISONE INTENSOL is prednisone. There are sixteen drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the prednisone profile page.
Summary for 088810
| Tradename: | PREDNISONE INTENSOL |
| Applicant: | Hikma |
| Ingredient: | prednisone |
| Patents: | 0 |
Pharmacology for NDA: 088810
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 088810
Suppliers and Packaging for NDA: 088810
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREDNISONE INTENSOL | prednisone | SOLUTION;ORAL | 088810 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-3721 | 0054-3721-44 | 30 mL in 1 BOTTLE, GLASS (0054-3721-44) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/ML | ||||
| Approval Date: | Feb 20, 1985 | TE: | RLD: | Yes | |||||
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