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Details for New Drug Application (NDA): 088481
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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 088481
Tradename: | DEXAMETHASONE |
Applicant: | Fera Pharms Llc |
Ingredient: | dexamethasone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 088481
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 088481
Suppliers and Packaging for NDA: 088481
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | dexamethasone | TABLET;ORAL | 088481 | ANDA | Fera Pharmaceuticals, LLC | 48102-045 | 48102-045-01 | 100 TABLET in 1 BOTTLE (48102-045-01) |
DEXAMETHASONE | dexamethasone | TABLET;ORAL | 088481 | ANDA | Fera Pharmaceuticals, LLC | 48102-046 | 48102-046-01 | 100 TABLET in 1 BOTTLE (48102-046-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
Approval Date: | Nov 28, 1983 | TE: | BP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Apr 28, 1983 | TE: | BP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.75MG | ||||
Approval Date: | Apr 28, 1983 | TE: | BP | RLD: | No |
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