Details for New Drug Application (NDA): 088252
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NDA 088252 describes DEXAMETHASONE 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 DEXAMETHASONE INTENSOL profile page.
The generic ingredient in DEXAMETHASONE INTENSOL is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
The generic ingredient in DEXAMETHASONE INTENSOL is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
Summary for 088252
| Tradename: | DEXAMETHASONE INTENSOL |
| Applicant: | Hikma |
| Ingredient: | dexamethasone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 088252
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 088252
Suppliers and Packaging for NDA: 088252
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXAMETHASONE INTENSOL | dexamethasone | CONCENTRATE;ORAL | 088252 | ANDA | Hikma Pharmaceuticals USA, Inc. | 0054-3176 | 0054-3176-44 | 30 mL in 1 BOTTLE, GLASS (0054-3176-44) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | 1MG/ML | ||||
| Approval Date: | Sep 1, 1983 | TE: | RLD: | No | |||||
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