68546-473-56 |
68546-473 |
HUMAN PRESCRIPTION DRUG |
AUSTEDO XR |
deutetrabenazine |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20240529 |
N/A |
NDA |
NDA216354 |
Teva Neuroscience, Inc. |
DEUTETRABENAZINE |
30 mg/1 |
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-473-56) |
68546-477-28 |
68546-477 |
HUMAN PRESCRIPTION DRUG |
AUSTEDO XR |
deutetrabenazine |
KIT |
|
20240701 |
N/A |
NDA |
NDA216354 |
Teva Neuroscience, Inc. |
|
|
1 KIT in 1 BLISTER PACK (68546-477-28) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07) |
68546-477-29 |
68546-477 |
HUMAN PRESCRIPTION DRUG |
AUSTEDO XR |
deutetrabenazine |
KIT |
|
20240701 |
N/A |
NDA |
NDA216354 |
Teva Neuroscience, Inc. |
|
|
1 BLISTER PACK in 1 CARTON (68546-477-29) / 1 KIT in 1 BLISTER PACK * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07) |
68546-471-56 |
68546-471 |
HUMAN PRESCRIPTION DRUG |
AUSTEDO XR |
deutetrabenazine |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20230221 |
N/A |
NDA |
NDA216354 |
Teva Neuroscience, Inc. |
DEUTETRABENAZINE |
12 mg/1 |
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-471-56) |
68546-476-56 |
68546-476 |
HUMAN PRESCRIPTION DRUG |
AUSTEDO XR |
deutetrabenazine |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20240529 |
N/A |
NDA |
NDA216354 |
Teva Neuroscience, Inc. |
DEUTETRABENAZINE |
48 mg/1 |
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-476-56) |
68546-470-56 |
68546-470 |
HUMAN PRESCRIPTION DRUG |
AUSTEDO XR |
deutetrabenazine |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20230221 |
N/A |
NDA |
NDA216354 |
Teva Neuroscience, Inc. |
DEUTETRABENAZINE |
6 mg/1 |
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-470-56) |
68546-475-56 |
68546-475 |
HUMAN PRESCRIPTION DRUG |
AUSTEDO XR |
deutetrabenazine |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20240529 |
N/A |
NDA |
NDA216354 |
Teva Neuroscience, Inc. |
DEUTETRABENAZINE |
42 mg/1 |
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-475-56) |
68546-490-42 |
68546-490 |
HUMAN PRESCRIPTION DRUG |
AUSTEDO XR |
deutetrabenazine |
KIT |
|
20230221 |
20250630 |
NDA |
NDA216354 |
Teva Neuroscience, Inc. |
|
|
2 KIT in 1 BLISTER PACK (68546-490-42) / 1 KIT in 1 KIT * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-163-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-165-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-161-15) |
68546-490-52 |
68546-490 |
HUMAN PRESCRIPTION DRUG |
AUSTEDO XR |
deutetrabenazine |
KIT |
|
20230221 |
20250630 |
NDA |
NDA216354 |
Teva Neuroscience, Inc. |
|
|
2 BLISTER PACK in 1 CARTON (68546-490-52) / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-163-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-165-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-161-15) |
68546-474-56 |
68546-474 |
HUMAN PRESCRIPTION DRUG |
AUSTEDO XR |
deutetrabenazine |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20240529 |
N/A |
NDA |
NDA216354 |
Teva Neuroscience, Inc. |
DEUTETRABENAZINE |
36 mg/1 |
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-474-56) |
68546-479-56 |
68546-479 |
HUMAN PRESCRIPTION DRUG |
AUSTEDO XR |
deutetrabenazine |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20240701 |
N/A |
NDA |
NDA216354 |
Teva Neuroscience, Inc. |
DEUTETRABENAZINE |
18 mg/1 |
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-479-56) |
68546-472-56 |
68546-472 |
HUMAN PRESCRIPTION DRUG |
AUSTEDO XR |
deutetrabenazine |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20230221 |
N/A |
NDA |
NDA216354 |
Teva Neuroscience, Inc. |
DEUTETRABENAZINE |
24 mg/1 |
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-472-56) |