01 3BOSENTAN
02 2EPOPROSTENOL SODIUM
03 3ILOPROST
04 1MACITENTAN
05 2MACITENTAN; TADALAFIL
06 1MIGLUSTAT
07 9SELEXIPAG
01 1CAPSULE;ORAL
02 2INJECTABLE;INJECTION
03 1POWDER;INTRAVENOUS
04 3SOLUTION;INHALATION
05 1TABLET, FOR SUSPENSION;ORAL
06 13TABLET;ORAL
01 10.2MG
02 10.4MG
03 10.6MG
04 10.8MG
05 11.2MG
06 11.4MG
07 11.6MG
08 11.8MG/VIAL
09 1100MG
10 110MCG/ML (10MCG/ML)
11 110MG
12 110MG;20MG
13 110MG;40MG
14 1125MG
15 11MG
16 120MCG/2ML (10MCG/ML)
17 120MCG/ML (20MCG/ML)
18 132MG
19 162.5MG
20 1EQ 0.5MG BASE/VIAL
21 1EQ 1.5MG BASE/VIAL
01 3DISCN
02 18RX
RLD : Yes
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : TRACLEER
Dosage Strength : 62.5MG
Approval Date : 2001-11-20
Application Number : 21290
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : TRACLEER
Dosage Strength : 125MG
Approval Date : 2001-11-20
Application Number : 21290
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code :
Dosage Form : TABLET, FOR SUSPENSION; ORAL
Proprietary Name : TRACLEER
Dosage Strength : 32MG
Approval Date : 2017-09-05
Application Number : 209279
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code : AP2
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : VELETRI
Dosage Strength : EQ 1.5MG BASE/VIAL
Approval Date : 2008-06-27
Application Number : 22260
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP2
RLD : Yes
TE Code : AP2
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : VELETRI
Dosage Strength : EQ 0.5MG BASE/VIAL
Approval Date : 2012-06-28
Application Number : 22260
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP2
RLD : No
TE Code :
Dosage Form : SOLUTION; INHALATION
Proprietary Name : VENTAVIS
Dosage Strength : 20MCG/2ML (10MCG/ML)
Approval Date : 2004-12-29
Application Number : 21779
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; INHALATION
Proprietary Name : VENTAVIS
Dosage Strength : 10MCG/ML (10MCG/ML)
Approval Date : 2005-12-08
Application Number : 21779
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION; INHALATION
Proprietary Name : VENTAVIS
Dosage Strength : 20MCG/ML (20MCG/ML)
Approval Date : 2009-08-07
Application Number : 21779
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : OPSUMIT
Dosage Strength : 10MG
Approval Date : 2013-10-18
Application Number : 204410
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : OPSYNVI
Dosage Strength : 10MG;20MG
Approval Date : 2024-03-22
Application Number : 218490
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
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