Details for New Drug Application (NDA): 088316
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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 088316
Tradename: | DEXAMETHASONE |
Applicant: | Hikma |
Ingredient: | dexamethasone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 088316
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 088316
Suppliers and Packaging for NDA: 088316
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | dexamethasone | TABLET;ORAL | 088316 | ANDA | Hikma Pharmaceuticals USA, Inc. | 0054-4186 | 0054-4186-25 | 100 TABLET in 1 BOTTLE, PLASTIC (0054-4186-25) |
DEXAMETHASONE | dexamethasone | TABLET;ORAL | 088316 | ANDA | Hikma Pharmaceuticals USA, Inc. | 0054-8183 | 0054-8183-25 | 10 BLISTER PACK in 1 CARTON (0054-8183-25) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
Approval Date: | Sep 15, 1983 | TE: | AB | RLD: | Yes |
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