Details for New Drug Application (NDA): 207768
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NDA 207768 describes TUZISTRA XR, which is a drug marketed by Tris Pharma Inc and is included in one NDA. There are two patents protecting this drug. Additional details are available on the TUZISTRA XR profile page.
The generic ingredient in TUZISTRA XR is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine polistirex; codeine polistirex profile page.
The generic ingredient in TUZISTRA XR is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine polistirex; codeine polistirex profile page.
Summary for 207768
| Tradename: | TUZISTRA XR |
| Applicant: | Tris Pharma Inc |
| Ingredient: | chlorpheniramine polistirex; codeine polistirex |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207768
Generic Entry Date for 207768*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION, EXTENDED RELEASE;ORAL |
*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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION, EXTENDED RELEASE;ORAL | Strength | EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML | ||||
| Approval Date: | Apr 30, 2015 | TE: | RLD: | Yes | |||||
| Patent: | 8,062,667 | Patent Expiration: | Mar 29, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,790,700 | Patent Expiration: | Mar 15, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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