71376-203-03 |
71376-203 |
HUMAN PRESCRIPTION DRUG |
JORNAY PM Extended-Release |
Methylphenidate Hydrochloride |
CAPSULE |
ORAL |
20190601 |
N/A |
NDA |
NDA209311 |
Ironshore Pharmaceuticals Inc. |
METHYLPHENIDATE HYDROCHLORIDE |
60 mg/1 |
100 CAPSULE in 1 BOTTLE (71376-203-03) |
71376-202-03 |
71376-202 |
HUMAN PRESCRIPTION DRUG |
JORNAY PM Extended-Release |
Methylphenidate Hydrochloride |
CAPSULE |
ORAL |
20190601 |
N/A |
NDA |
NDA209311 |
Ironshore Pharmaceuticals Inc. |
METHYLPHENIDATE HYDROCHLORIDE |
40 mg/1 |
100 CAPSULE in 1 BOTTLE (71376-202-03) |
71376-201-03 |
71376-201 |
HUMAN PRESCRIPTION DRUG |
JORNAY PM Extended-Release |
Methylphenidate Hydrochloride |
CAPSULE |
ORAL |
20190601 |
N/A |
NDA |
NDA209311 |
Ironshore Pharmaceuticals Inc. |
METHYLPHENIDATE HYDROCHLORIDE |
20 mg/1 |
100 CAPSULE in 1 BOTTLE (71376-201-03) |
71376-205-03 |
71376-205 |
HUMAN PRESCRIPTION DRUG |
JORNAY PM Extended-Release |
Methylphenidate Hydrochloride |
CAPSULE |
ORAL |
20190601 |
N/A |
NDA |
NDA209311 |
Ironshore Pharmaceuticals Inc. |
METHYLPHENIDATE HYDROCHLORIDE |
100 mg/1 |
100 CAPSULE in 1 BOTTLE (71376-205-03) |
71376-204-03 |
71376-204 |
HUMAN PRESCRIPTION DRUG |
JORNAY PM Extended-Release |
Methylphenidate Hydrochloride |
CAPSULE |
ORAL |
20190601 |
N/A |
NDA |
NDA209311 |
Ironshore Pharmaceuticals Inc. |
METHYLPHENIDATE HYDROCHLORIDE |
80 mg/1 |
100 CAPSULE in 1 BOTTLE (71376-204-03) |