| 0078-0431-05 |
0078-0431 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
20260630 |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
10 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0431-05) |
| 0078-0608-05 |
0078-0608 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
20260731 |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
25 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0608-05) |
| 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) |
| 66758-235-31 |
66758-235 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20251117 |
N/A |
NDA |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
5 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-235-31) |
| 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) |
| 66758-239-31 |
66758-239 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20251117 |
N/A |
NDA |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
25 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-239-31) |
| 0078-0433-05 |
0078-0433 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
20261031 |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
30 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0433-05) |
| 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) |
| 66758-241-01 |
66758-241 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20251015 |
N/A |
NDA |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
35 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-241-01) |
| 66758-241-31 |
66758-241 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20251117 |
N/A |
NDA |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
35 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-241-31) |
| 0078-0493-05 |
0078-0493 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
20260831 |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
15 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0493-05) |
| 0078-0432-05 |
0078-0432 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
20261231 |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
20 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0432-05) |
| 0078-0609-05 |
0078-0609 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
20260731 |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
35 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0609-05) |
| 66758-236-01 |
66758-236 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20250215 |
N/A |
NDA |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
10 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-236-01) |
| 66758-240-01 |
66758-240 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20250601 |
N/A |
NDA |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
30 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-240-01) |
| 66758-240-31 |
66758-240 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20251117 |
N/A |
NDA |
NDA021802 |
Sandoz Inc |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
30 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-240-31) |
| 0078-0430-05 |
0078-0430 |
HUMAN PRESCRIPTION DRUG |
Focalin XR |
dexmethylphenidate hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20050531 |
20260831 |
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 |
20260228 |
NDA |
NDA021802 |
Novartis Pharmaceuticals Corporation |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
40 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0434-05) |
| 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) |