Details for New Drug Application (NDA): 214962
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The generic ingredient in TASCENSO ODT is fingolimod lauryl sulfate. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fingolimod lauryl sulfate profile page.
Summary for 214962
Tradename: | TASCENSO ODT |
Applicant: | Cycle |
Ingredient: | fingolimod lauryl sulfate |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214962
Generic Entry Date for 214962*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, ORALLY DISINTEGRATING;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.
Pharmacology for NDA: 214962
Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Suppliers and Packaging for NDA: 214962
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962 | NDA | Cycle Pharmaceuticals Ltd | 70709-062 | 70709-062-30 | 3 BLISTER PACK in 1 CARTON (70709-062-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962 | NDA | Cycle Pharmaceuticals Ltd | 70709-065 | 70709-065-30 | 3 BLISTER PACK in 1 CARTON (70709-065-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | EQ 0.25MG BASE | ||||
Approval Date: | Dec 23, 2021 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 19, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF MULTIPLE SCLEROSIS IN PEDIATRIC PATIENTS 10 YEARS OF AGE AND OLDER AND WEIGHING LESS THAN OR EQUAL TO 40 KG | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 19, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 19, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? |
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