Details for New Drug Application (NDA): 212535
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NDA 212535 describes NOURESS, which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. There are nineteen patents protecting this drug. Additional details are available on the NOURESS profile page.
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.
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212535
Generic Entry Date for 212535*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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: | ⤷ Start Trial | 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: | ⤷ Start Trial | Patent Expiration: | Mar 15, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | 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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