| 66215-608-06 |
66215-608 |
HUMAN PRESCRIPTION DRUG |
UPTRAVI |
Selexipag |
TABLET, COATED |
ORAL |
20151221 |
N/A |
NDA |
NDA207947 |
Actelion Pharmaceuticals US, Inc. |
SELEXIPAG |
800 ug/1 |
1 BOTTLE in 1 CARTON (66215-608-06) / 60 TABLET, COATED in 1 BOTTLE |
| 66215-616-06 |
66215-616 |
HUMAN PRESCRIPTION DRUG |
UPTRAVI |
Selexipag |
TABLET, COATED |
ORAL |
20151221 |
N/A |
NDA |
NDA207947 |
Actelion Pharmaceuticals US, Inc. |
SELEXIPAG |
1600 ug/1 |
1 BOTTLE in 1 CARTON (66215-616-06) / 60 TABLET, COATED in 1 BOTTLE |
| 66215-606-06 |
66215-606 |
HUMAN PRESCRIPTION DRUG |
UPTRAVI |
Selexipag |
TABLET, COATED |
ORAL |
20151221 |
N/A |
NDA |
NDA207947 |
Actelion Pharmaceuticals US, Inc. |
SELEXIPAG |
600 ug/1 |
1 BOTTLE in 1 CARTON (66215-606-06) / 60 TABLET, COATED in 1 BOTTLE |
| 66215-614-06 |
66215-614 |
HUMAN PRESCRIPTION DRUG |
UPTRAVI |
Selexipag |
TABLET, COATED |
ORAL |
20151221 |
N/A |
NDA |
NDA207947 |
Actelion Pharmaceuticals US, Inc. |
SELEXIPAG |
1400 ug/1 |
1 BOTTLE in 1 CARTON (66215-614-06) / 60 TABLET, COATED in 1 BOTTLE |
| 66215-602-06 |
66215-602 |
HUMAN PRESCRIPTION DRUG |
UPTRAVI |
Selexipag |
TABLET, COATED |
ORAL |
20151221 |
N/A |
NDA |
NDA207947 |
Actelion Pharmaceuticals US, Inc. |
SELEXIPAG |
200 ug/1 |
1 BOTTLE in 1 CARTON (66215-602-06) / 60 TABLET, COATED in 1 BOTTLE |
| 66215-602-14 |
66215-602 |
HUMAN PRESCRIPTION DRUG |
UPTRAVI |
Selexipag |
TABLET, COATED |
ORAL |
20151221 |
N/A |
NDA |
NDA207947 |
Actelion Pharmaceuticals US, Inc. |
SELEXIPAG |
200 ug/1 |
1 BOTTLE in 1 CARTON (66215-602-14) / 140 TABLET, COATED in 1 BOTTLE |
| 66215-610-06 |
66215-610 |
HUMAN PRESCRIPTION DRUG |
UPTRAVI |
Selexipag |
TABLET, COATED |
ORAL |
20151221 |
N/A |
NDA |
NDA207947 |
Actelion Pharmaceuticals US, Inc. |
SELEXIPAG |
1000 ug/1 |
1 BOTTLE in 1 CARTON (66215-610-06) / 60 TABLET, COATED in 1 BOTTLE |
| 66215-628-20 |
66215-628 |
HUMAN PRESCRIPTION DRUG |
UPTRAVI Titration Pack |
Selexipag |
KIT |
|
20151221 |
N/A |
NDA |
NDA207947 |
Actelion Pharmaceuticals US, Inc. |
|
|
1 KIT in 1 CARTON (66215-628-20) * 1 BOTTLE in 1 CARTON / 140 TABLET, COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 60 TABLET, COATED in 1 BOTTLE |
| 66215-604-06 |
66215-604 |
HUMAN PRESCRIPTION DRUG |
UPTRAVI |
Selexipag |
TABLET, COATED |
ORAL |
20151221 |
N/A |
NDA |
NDA207947 |
Actelion Pharmaceuticals US, Inc. |
SELEXIPAG |
400 ug/1 |
1 BOTTLE in 1 CARTON (66215-604-06) / 60 TABLET, COATED in 1 BOTTLE |
| 66215-612-06 |
66215-612 |
HUMAN PRESCRIPTION DRUG |
UPTRAVI |
Selexipag |
TABLET, COATED |
ORAL |
20151221 |
N/A |
NDA |
NDA207947 |
Actelion Pharmaceuticals US, Inc. |
SELEXIPAG |
1200 ug/1 |
1 BOTTLE in 1 CARTON (66215-612-06) / 60 TABLET, COATED in 1 BOTTLE |