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Last Updated: March 28, 2024

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 one supplier. 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 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
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:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 3, 2019TE: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 TrialPatent Expiration:Dec 18, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Dec 18, 2037Product Flag?YSubstance 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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