Details for New Drug Application (NDA): 212535
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The generic ingredient in NOURESS 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 212535
Tradename: | NOURESS |
Applicant: | Baxter Hlthcare Corp |
Ingredient: | cysteine hydrochloride |
Patents: | 19 |
Suppliers and Packaging for NDA: 212535
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NOURESS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 212535 | NDA | Baxter Healthcare Corporation | 0338-9645 | 0338-9645-01 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0338-9645-01) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/10ML (50MG/ML) | ||||
Approval Date: | Dec 13, 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: | Mar 15, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 15, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF INTRAVENOUSLY ADMINISTERING A DILUTED CYSTEINE HYDROCHLORIDE SOLUTION TO A NEONATE IN NEED THEREOF |
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