Details for New Drug Application (NDA): 215106
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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 215106
Tradename: | DEXAMETHASONE |
Applicant: | Amneal |
Ingredient: | dexamethasone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215106
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 215106
Suppliers and Packaging for NDA: 215106
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | dexamethasone | TABLET;ORAL | 215106 | ANDA | Major Pharmaceuticals | 0904-7266 | 0904-7266-61 | 100 BLISTER PACK in 1 CARTON (0904-7266-61) / 1 TABLET in 1 BLISTER PACK |
DEXAMETHASONE | dexamethasone | TABLET;ORAL | 215106 | ANDA | Cardinal Health 107, LLC | 55154-4315 | 55154-4315-0 | 10 BLISTER PACK in 1 BAG (55154-4315-0) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
Approval Date: | Oct 14, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
Approval Date: | Oct 14, 2021 | TE: | AB | RLD: | No |
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