75987-140-13 |
75987-140 |
HUMAN PRESCRIPTION DRUG |
PROCYSBI |
Cysteamine bitartrate |
GRANULE, DELAYED RELEASE |
ORAL |
20200214 |
N/A |
NDA |
NDA213491 |
Horizon Therapeutics USA, Inc. |
CYSTEAMINE BITARTRATE |
75 mg/1 |
60 PACKET in 1 CARTON (75987-140-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET |
75987-140-14 |
75987-140 |
HUMAN PRESCRIPTION DRUG |
PROCYSBI |
Cysteamine bitartrate |
GRANULE, DELAYED RELEASE |
ORAL |
20200214 |
N/A |
NDA |
NDA213491 |
Horizon Therapeutics USA, Inc. |
CYSTEAMINE BITARTRATE |
75 mg/1 |
120 PACKET in 1 CARTON (75987-140-14) / 1 GRANULE, DELAYED RELEASE in 1 PACKET |
75987-145-13 |
75987-145 |
HUMAN PRESCRIPTION DRUG |
PROCYSBI |
Cysteamine bitartrate |
GRANULE, DELAYED RELEASE |
ORAL |
20200214 |
N/A |
NDA |
NDA213491 |
Horizon Therapeutics USA, Inc. |
CYSTEAMINE BITARTRATE |
300 mg/1 |
60 PACKET in 1 CARTON (75987-145-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET |
75987-145-14 |
75987-145 |
HUMAN PRESCRIPTION DRUG |
PROCYSBI |
Cysteamine bitartrate |
GRANULE, DELAYED RELEASE |
ORAL |
20200214 |
N/A |
NDA |
NDA213491 |
Horizon Therapeutics USA, Inc. |
CYSTEAMINE BITARTRATE |
300 mg/1 |
120 PACKET in 1 CARTON (75987-145-14) / 1 GRANULE, DELAYED RELEASE in 1 PACKET |