Details for New Drug Application (NDA): 211379
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The generic ingredient in HEMADY is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
Summary for 211379
Tradename: | HEMADY |
Applicant: | Dexcel |
Ingredient: | dexamethasone |
Patents: | 2 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211379
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 211379
Suppliers and Packaging for NDA: 211379
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HEMADY | dexamethasone | TABLET;ORAL | 211379 | NDA | Edenbridge Pharmaceuticals LLC. | 82111-955 | 82111-955-01 | 1 BOTTLE in 1 CARTON (82111-955-01) / 24 TABLET in 1 BOTTLE |
HEMADY | dexamethasone | TABLET;ORAL | 211379 | NDA | Edenbridge Pharmaceuticals LLC. | 82111-955 | 82111-955-02 | 1 BOTTLE in 1 CARTON (82111-955-02) / 100 TABLET in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Oct 3, 2019 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Oct 3, 2026 | ||||||||
Regulatory Exclusivity Use: | INDICATED IN COMBINATION WITH OTHER ANTI-MYELOMA PRODUCTS FOR THE TREATMENT OF ADULTS WITH MULTIPLE MYELOMA (MM) | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 18, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 18, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | A METHOD OF TREATING ADULTS WITH MULTIPLE MYELOMA USING DEXAMETHASONE IN COMBINATION WITH AN ANTI-MYELOMA PRODUCT |
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