Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210660

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ELCYS (CYSTEINE HYDROCHLORIDE)
500MG/10ML (50MG/ML)
Marketing Status: Prescription

Active Ingredient: CYSTEINE HYDROCHLORIDE
Proprietary Name: ELCYS
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 500MG/10ML (50MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210660
Product Number: 001
Approval Date: Apr 16, 2019
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ELCYS (CYSTEINE HYDROCHLORIDE)
2500MG/50ML (50MG/ML)
Marketing Status: Discontinued

Active Ingredient: CYSTEINE HYDROCHLORIDE
Proprietary Name: ELCYS
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 2500MG/50ML (50MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210660
Product Number: 002
Approval Date: Dec 4, 2023
Applicant Holder Full Name: EXELA PHARMA SCIENCES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information