TIGLUTIK is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Itf Pharma, Inc.. The primary component is Riluzole.
Product ID | 70726-0303_67b29266-d9a4-4a83-8f07-f41ec96cb341 |
NDC | 70726-0303 |
Product Type | Human Prescription Drug |
Proprietary Name | TIGLUTIK |
Generic Name | Riluzole |
Dosage Form | Liquid |
Route of Administration | ORAL |
Marketing Start Date | 2018-09-21 |
Marketing Category | NDA / NDA |
Application Number | NDA209080 |
Labeler Name | Itf Pharma, Inc. |
Substance Name | RILUZOLE |
Active Ingredient Strength | 50 mg/10mL |
Pharm Classes | Benzothiazole [EPC],Benzothiazoles [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2018-09-21 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA209080 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2018-09-21 |
Inactivation Date | 2020-01-31 |
Reactivation Date | 2020-03-12 |
Marketing Category | NDA |
Application Number | NDA209080 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2018-09-21 |
Ingredient | Strength |
---|---|
RILUZOLE | 50 mg/10mL |
SPL SET ID: | 75d68f19-4208-109e-e053-2991aa0ac857 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
70726-0303 | TIGLUTIK | Riluzole |
10094-350 | EXSERVAN | riluzole |
70510-2201 | Exservan | riluzole |
70510-2202 | Exservan | riluzole |
70515-700 | Rilutek | riluzole |
0378-4145 | Riluzole | riluzole |
42291-775 | Riluzole | riluzole |
60505-3285 | RILUZOLE | RILUZOLE |
62756-538 | Riluzole | Riluzole |
64980-191 | Riluzole | riluzole |
67877-286 | Riluzole | Riluzole |
68084-908 | RILUZOLE | RILUZOLE |
68462-381 | riluzole | riluzole |
69076-200 | Riluzole | riluzole |
69076-611 | Riluzole | Riluzole |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TIGLUTIK 98658037 not registered Live/Pending |
ITALFARMACO S.A. 2024-07-19 |
TIGLUTIK 87402684 5764127 Live/Registered |
ITALFARMACO S.A. 2017-04-07 |