0078-0430-05 |
0078-0430 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
N/A |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
5 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0430-05) |
0078-0434-05 |
0078-0434 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
N/A |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
40 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0434-05) |
0781-2684-01 |
0781-2684 |
HUMAN PRESCRIPTION DRUG |
Dexmethylphenidate Hydrochloride Extended-Release |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20140128 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
15 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2684-01) |
0781-2688-01 |
0781-2688 |
HUMAN PRESCRIPTION DRUG |
Dexmethylphenidate Hydrochloride Extended-Release |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20170105 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
35 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2688-01) |
66758-238-01 |
66758-238 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20241004 |
N/A |
NDA |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
20 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-238-01) |
66758-242-01 |
66758-242 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20241115 |
N/A |
NDA |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
40 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-242-01) |
0078-0433-05 |
0078-0433 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
N/A |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
30 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0433-05) |
0781-2683-01 |
0781-2683 |
HUMAN PRESCRIPTION DRUG |
Dexmethylphenidate Hydrochloride Extended-Release |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20150203 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
10 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2683-01) |
0781-2687-01 |
0781-2687 |
HUMAN PRESCRIPTION DRUG |
Dexmethylphenidate Hydrochloride Extended-Release |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20140114 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
30 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2687-01) |
66758-237-01 |
66758-237 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20241004 |
N/A |
NDA |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
15 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-237-01) |
0078-0609-05 |
0078-0609 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
N/A |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
35 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0609-05) |
0078-0431-05 |
0078-0431 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
N/A |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
10 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0431-05) |
0078-0493-05 |
0078-0493 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
N/A |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
15 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0493-05) |
0781-2685-01 |
0781-2685 |
HUMAN PRESCRIPTION DRUG |
Dexmethylphenidate Hydrochloride Extended-Release |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20150622 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
20 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2685-01) |
66758-235-01 |
66758-235 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20250115 |
N/A |
NDA |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
5 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-235-01) |
66758-239-01 |
66758-239 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20250201 |
N/A |
NDA |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
25 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-239-01) |
0781-2689-01 |
0781-2689 |
HUMAN PRESCRIPTION DRUG |
Dexmethylphenidate Hydrochloride Extended-Release |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20140305 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
40 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2689-01) |
0078-0432-05 |
0078-0432 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
N/A |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
20 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0432-05) |
0781-2682-01 |
0781-2682 |
HUMAN PRESCRIPTION DRUG |
Dexmethylphenidate Hydrochloride Extended-Release |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20141120 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
5 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2682-01) |
0781-2686-01 |
0781-2686 |
HUMAN PRESCRIPTION DRUG |
Dexmethylphenidate Hydrochloride Extended-Release |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20170105 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
25 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2686-01) |