Details for New Drug Application (NDA): 211379
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NDA 211379 describes HEMADY, which is a drug marketed by Dexcel and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the HEMADY profile page.
The generic ingredient in HEMADY is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
The generic ingredient in HEMADY is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-three 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 |
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 | Acrotech Biopharma Inc | 72893-015 | 72893-015-06 | 100 TABLET in 1 BOTTLE (72893-015-06) |
| HEMADY | dexamethasone | TABLET;ORAL | 211379 | NDA | Acrotech Biopharma Inc | 72893-015 | 72893-015-24 | 24 TABLET in 1 BOTTLE (72893-015-24) |
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: | ⤷ Sign Up | Patent Expiration: | Dec 18, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | 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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