Details for New Drug Application (NDA): 090891
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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 090891
Tradename: | DEXAMETHASONE |
Applicant: | Lyne |
Ingredient: | dexamethasone |
Patents: | 0 |
Pharmacology for NDA: 090891
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 090891
Suppliers and Packaging for NDA: 090891
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | dexamethasone | ELIXIR;ORAL | 090891 | ANDA | Rising Pharma Holdings, Inc. | 64980-509 | 64980-509-24 | 237 mL in 1 BOTTLE, PLASTIC (64980-509-24) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | ELIXIR;ORAL | Strength | 0.5MG/5ML | ||||
Approval Date: | Jul 12, 2011 | TE: | AA | RLD: | No |
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