Details for New Drug Application (NDA): 210660
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The generic ingredient in ELCYS is cysteine hydrochloride. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteine hydrochloride profile page.
Summary for 210660
Tradename: | ELCYS |
Applicant: | Exela Pharma |
Ingredient: | cysteine hydrochloride |
Patents: | 16 |
Suppliers and Packaging for NDA: 210660
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660 | NDA | Exela Pharma Sciences, LLC | 51754-1007 | 51754-1007-1 | 10 mL in 1 VIAL (51754-1007-1) |
ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660 | NDA | Exela Pharma Sciences, LLC | 51754-1007 | 51754-1007-3 | 100 mL in 1 CARTON (51754-1007-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/10ML (50MG/ML) | ||||
Approval Date: | Apr 16, 2019 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 15, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 15, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 15, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? |
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