Details for New Drug Application (NDA): 091188
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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 091188
Tradename: | DEXAMETHASONE |
Applicant: | Chartwell Molecular |
Ingredient: | dexamethasone |
Patents: | 0 |
Pharmacology for NDA: 091188
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 091188
Suppliers and Packaging for NDA: 091188
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | dexamethasone | ELIXIR;ORAL | 091188 | ANDA | Chartwell RX, LLC | 62135-114 | 62135-114-37 | 237 mL in 1 BOTTLE (62135-114-37) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | ELIXIR;ORAL | Strength | 0.5MG/5ML | ||||
Approval Date: | May 11, 2011 | TE: | AA | RLD: | No |
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