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`Additional Information about Patents
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`Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
`Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may
`include drug substance and/or drug product claims that are not indicated in the listing.
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`Patent and Exclusivity for: N210660
`
`Product 001
`CYSTEINE HYDROCHLORIDE (ELCYS) SOLUTION 500MG/10ML (50MG/ML)
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`001
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`10478453 01/15/2039
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`U-2752
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`Requested
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`Submission
`Date
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`11/19/2019
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`Product Details for NDA 210660
`
`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 (patent_info.cfm?
`Product_No=001&Appl_No=210660&Appl_type=N)
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