Austedo is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Teva Neuroscience, Inc.. The primary component is Deutetrabenazine.
Product ID | 68546-171_0de1abef-824f-4d54-9acf-30aa63d87a5a |
NDC | 68546-171 |
Product Type | Human Prescription Drug |
Proprietary Name | Austedo |
Generic Name | Deutetrabenazine |
Dosage Form | Tablet, Coated |
Route of Administration | ORAL |
Marketing Start Date | 2017-04-12 |
Marketing Category | NDA / NDA |
Application Number | NDA208082 |
Labeler Name | Teva Neuroscience, Inc. |
Substance Name | DEUTETRABENAZINE |
Active Ingredient Strength | 9 mg/1 |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2017-04-12 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA208082 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2017-04-12 |
Marketing Category | NDA |
Application Number | NDA208082 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2017-04-12 |
Ingredient | Strength |
---|---|
DEUTETRABENAZINE | 9 mg/1 |
SPL SET ID: | 7ea3c60a-45c7-44cc-afc2-d87fa53993c0 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
68546-170 | Austedo | Deutetrabenazine |
68546-171 | Austedo | Deutetrabenazine |
68546-172 | Austedo | Deutetrabenazine |
68546-176 | AUSTEDO | deutetrabenazine |
68546-177 | AUSTEDO | deutetrabenazine |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AUSTEDO 86752573 5396839 Live/Registered |
Auspex Pharmaceuticals, Inc. 2015-09-10 |
AUSTEDO 86492765 5223589 Live/Registered |
Auspex Pharmaceuticals, Inc. 2014-12-30 |
AUSTEDO 86492763 5223588 Live/Registered |
Auspex Pharmaceuticals, Inc. 2014-12-30 |