Details for New Drug Application (NDA): 088248
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The generic ingredient in DEXAMETHASONE is dexamethasone acetate. There are thirty-nine drug master file entries for this compound. Additional details are available on the dexamethasone acetate profile page.
Summary for 088248
Tradename: | DEXAMETHASONE |
Applicant: | Hikma |
Ingredient: | dexamethasone |
Patents: | 0 |
Pharmacology for NDA: 088248
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 088248
Suppliers and Packaging for NDA: 088248
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | dexamethasone | SOLUTION;ORAL | 088248 | ANDA | Hikma Pharmaceuticals USA, Inc. | 0054-3177 | 0054-3177-57 | 240 mL in 1 BOTTLE, PLASTIC (0054-3177-57) |
DEXAMETHASONE | dexamethasone | SOLUTION;ORAL | 088248 | ANDA | Hikma Pharmaceuticals USA, Inc. | 0054-3177 | 0054-3177-63 | 500 mL in 1 BOTTLE, PLASTIC (0054-3177-63) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 0.5MG/5ML | ||||
Approval Date: | Sep 1, 1983 | TE: | RLD: | Yes |
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