Home Applications 207947 Application 207947
Type NDA
Sponsor ACTELION PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 UPTRAVI SELEXIPAG TABLET;ORAL 0.2MG Yes No 002 UPTRAVI SELEXIPAG TABLET;ORAL 0.4MG Yes Yes 003 UPTRAVI SELEXIPAG TABLET;ORAL 0.6MG Yes No 004 UPTRAVI SELEXIPAG TABLET;ORAL 0.8MG Yes No 005 UPTRAVI SELEXIPAG TABLET;ORAL 1MG Yes No 006 UPTRAVI SELEXIPAG TABLET;ORAL 1.2MG Yes No 007 UPTRAVI SELEXIPAG TABLET;ORAL 1.4MG Yes No 008 UPTRAVI SELEXIPAG TABLET;ORAL 1.6MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 10 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207947-001 UPTRAVI SELEXIPAG 0.2MG TABLET / ORAL AB RLD 2015-12-21 N207947-002 UPTRAVI SELEXIPAG 0.4MG TABLET / ORAL AB RLD, RS 2015-12-21 N207947-003 UPTRAVI SELEXIPAG 0.6MG TABLET / ORAL AB RLD 2015-12-21 N207947-004 UPTRAVI SELEXIPAG 0.8MG TABLET / ORAL AB RLD 2015-12-21 N207947-005 UPTRAVI SELEXIPAG 1MG TABLET / ORAL AB RLD 2015-12-21 N207947-006 UPTRAVI SELEXIPAG 1.2MG TABLET / ORAL AB RLD 2015-12-21 N207947-007 UPTRAVI SELEXIPAG 1.4MG TABLET / ORAL AB RLD 2015-12-21 N207947-008 UPTRAVI SELEXIPAG 1.6MG TABLET / ORAL AB RLD 2015-12-21 N207947-010 UPTRAVI SELEXIPAG 0.1MG TABLET / ORAL RLD 2026-05-23 N207947-011 UPTRAVI SELEXIPAG 0.15MG TABLET / ORAL RLD 2026-05-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 8 matching rows.
Orange Book patents# Current patent rows page 1 of 2 · 120 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207947-001 7205302 2026-10-31 U-1797 Drug substance, Drug product 2016-01-19 N207947-001 7205302*PED 2027-04-30 Pediatric extension N207947-001 9173881 2029-08-12 U-1798 2016-01-19 N207947-001 9173881*PED 2030-02-12 Pediatric extension N207947-001 9284280 2030-06-25 U-1831 2016-04-12 N207947-001 8791122 2030-08-01 Drug substance, Drug product 2016-01-19 N207947-001 9284280*PED 2030-12-25 Pediatric extension N207947-001 8791122*PED 2031-02-01 Pediatric extension N207947-001 10821108 2036-12-01 U-2992 Drug product 2020-12-02 N207947-001 10828298 2036-12-01 U-2991 Drug product 2020-12-02 N207947-001 10821108*PED 2037-06-01 Pediatric extension N207947-001 10828298*PED 2037-06-01 Pediatric extension N207947-002 7205302 2026-10-31 U-1797 Drug substance, Drug product 2016-01-19 N207947-002 7205302*PED 2027-04-30 Pediatric extension N207947-002 9173881 2029-08-12 U-1798 2016-01-19 N207947-002 9173881*PED 2030-02-12 Pediatric extension N207947-002 9284280 2030-06-25 U-1831 2016-04-12 N207947-002 8791122 2030-08-01 Drug substance, Drug product 2016-01-19 N207947-002 9284280*PED 2030-12-25 Pediatric extension N207947-002 8791122*PED 2031-02-01 Pediatric extension N207947-002 10821108 2036-12-01 U-2992 Drug product 2020-12-02 N207947-002 10828298 2036-12-01 U-2991 Drug product 2020-12-02 N207947-002 10821108*PED 2037-06-01 Pediatric extension N207947-002 10828298*PED 2037-06-01 Pediatric extension N207947-003 7205302 2026-10-31 U-1797 Drug substance, Drug product 2016-01-19 N207947-003 7205302*PED 2027-04-30 Pediatric extension N207947-003 9173881 2029-08-12 U-1798 2016-01-19 N207947-003 9173881*PED 2030-02-12 Pediatric extension N207947-003 9284280 2030-06-25 U-1831 2016-04-12 N207947-003 8791122 2030-08-01 Drug substance, Drug product 2016-01-19 N207947-003 9284280*PED 2030-12-25 Pediatric extension N207947-003 8791122*PED 2031-02-01 Pediatric extension N207947-003 10821108 2036-12-01 U-2992 Drug product 2020-12-02 N207947-003 10828298 2036-12-01 U-2991 Drug product 2020-12-02 N207947-003 10821108*PED 2037-06-01 Pediatric extension N207947-003 10828298*PED 2037-06-01 Pediatric extension N207947-004 7205302 2026-10-31 U-1797 Drug substance, Drug product 2016-01-19 N207947-004 7205302*PED 2027-04-30 Pediatric extension N207947-004 9173881 2029-08-12 U-1798 2016-01-19 N207947-004 9173881*PED 2030-02-12 Pediatric extension N207947-004 9284280 2030-06-25 U-1831 2016-04-12 N207947-004 8791122 2030-08-01 Drug substance, Drug product 2016-01-19 N207947-004 9284280*PED 2030-12-25 Pediatric extension N207947-004 8791122*PED 2031-02-01 Pediatric extension N207947-004 10821108 2036-12-01 U-2992 Drug product 2020-12-02 N207947-004 10828298 2036-12-01 U-2991 Drug product 2020-12-02 N207947-004 10821108*PED 2037-06-01 Pediatric extension N207947-004 10828298*PED 2037-06-01 Pediatric extension N207947-005 7205302 2026-10-31 U-1797 Drug substance, Drug product 2016-01-19 N207947-005 7205302*PED 2027-04-30 Pediatric extension N207947-005 9173881 2029-08-12 U-1798 2016-01-19 N207947-005 9173881*PED 2030-02-12 Pediatric extension N207947-005 9284280 2030-06-25 U-1831 2016-04-12 N207947-005 8791122 2030-08-01 Drug substance, Drug product 2016-01-19 N207947-005 9284280*PED 2030-12-25 Pediatric extension N207947-005 8791122*PED 2031-02-01 Pediatric extension N207947-005 10821108 2036-12-01 U-2992 Drug product 2020-12-02 N207947-005 10828298 2036-12-01 U-2991 Drug product 2020-12-02 N207947-005 10821108*PED 2037-06-01 Pediatric extension N207947-005 10828298*PED 2037-06-01 Pediatric extension N207947-006 7205302 2026-10-31 U-1797 Drug substance, Drug product 2016-01-19 N207947-006 7205302*PED 2027-04-30 Pediatric extension N207947-006 9173881 2029-08-12 U-1798 2016-01-19 N207947-006 9173881*PED 2030-02-12 Pediatric extension N207947-006 9284280 2030-06-25 U-1831 2016-04-12 N207947-006 8791122 2030-08-01 Drug substance, Drug product 2016-01-19 N207947-006 9284280*PED 2030-12-25 Pediatric extension N207947-006 8791122*PED 2031-02-01 Pediatric extension N207947-006 10821108 2036-12-01 U-2992 Drug product 2020-12-02 N207947-006 10828298 2036-12-01 U-2991 Drug product 2020-12-02 N207947-006 10821108*PED 2037-06-01 Pediatric extension N207947-006 10828298*PED 2037-06-01 Pediatric extension N207947-007 7205302 2026-10-31 U-1797 Drug substance, Drug product 2016-01-19 N207947-007 7205302*PED 2027-04-30 Pediatric extension N207947-007 9173881 2029-08-12 U-1798 2016-01-19 N207947-007 9173881*PED 2030-02-12 Pediatric extension N207947-007 9284280 2030-06-25 U-1831 2016-04-12 N207947-007 8791122 2030-08-01 Drug substance, Drug product 2016-01-19 N207947-007 9284280*PED 2030-12-25 Pediatric extension N207947-007 8791122*PED 2031-02-01 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 20 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 9 · 350 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N207947-001 UPTRAVI 0.2MG TABLET / ORAL AB RLD 2015-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 UPTRAVI 0.4MG TABLET / ORAL AB RLD, RS 2015-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 UPTRAVI 0.6MG TABLET / ORAL AB RLD 2015-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-004 UPTRAVI 0.8MG TABLET / ORAL AB RLD 2015-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-005 UPTRAVI 1MG TABLET / ORAL AB RLD 2015-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-006 UPTRAVI 1.2MG TABLET / ORAL AB RLD 2015-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-007 UPTRAVI 1.4MG TABLET / ORAL AB RLD 2015-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-008 UPTRAVI 1.6MG TABLET / ORAL AB RLD 2015-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-010 UPTRAVI 0.1MG TABLET / ORAL RLD 2026-05-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-011 UPTRAVI 0.15MG TABLET / ORAL RLD 2026-05-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207947-001 UPTRAVI 0.2MG TABLET / ORAL AB RLD 2015-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207947-002 UPTRAVI 0.4MG TABLET / ORAL AB RLD, RS 2015-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207947-003 UPTRAVI 0.6MG TABLET / ORAL AB RLD 2015-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207947-004 UPTRAVI 0.8MG TABLET / ORAL AB RLD 2015-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207947-005 UPTRAVI 1MG TABLET / ORAL AB RLD 2015-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207947-006 UPTRAVI 1.2MG TABLET / ORAL AB RLD 2015-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207947-007 UPTRAVI 1.4MG TABLET / ORAL AB RLD 2015-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207947-008 UPTRAVI 1.6MG TABLET / ORAL AB RLD 2015-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207947-010 UPTRAVI 0.1MG TABLET / ORAL RLD 2026-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207947-011 UPTRAVI 0.15MG TABLET / ORAL RLD 2026-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207947-001 UPTRAVI 0.2MG TABLET / ORAL AB RLD 2015-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207947-002 UPTRAVI 0.4MG TABLET / ORAL AB RLD, RS 2015-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207947-003 UPTRAVI 0.6MG TABLET / ORAL AB RLD 2015-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207947-004 UPTRAVI 0.8MG TABLET / ORAL AB RLD 2015-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207947-005 UPTRAVI 1MG TABLET / ORAL RLD 2015-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207947-006 UPTRAVI 1.2MG TABLET / ORAL RLD 2015-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207947-007 UPTRAVI 1.4MG TABLET / ORAL AB RLD 2015-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207947-008 UPTRAVI 1.6MG TABLET / ORAL AB RLD 2015-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207947-001 UPTRAVI 0.2MG TABLET / ORAL AB RLD 2015-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207947-002 UPTRAVI 0.4MG TABLET / ORAL AB RLD, RS 2015-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207947-003 UPTRAVI 0.6MG TABLET / ORAL AB RLD 2015-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207947-004 UPTRAVI 0.8MG TABLET / ORAL AB RLD 2015-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207947-005 UPTRAVI 1MG TABLET / ORAL RLD 2015-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207947-006 UPTRAVI 1.2MG TABLET / ORAL RLD 2015-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207947-007 UPTRAVI 1.4MG TABLET / ORAL AB RLD 2015-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207947-008 UPTRAVI 1.6MG TABLET / ORAL AB RLD 2015-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207947-001 UPTRAVI 0.2MG TABLET / ORAL AB RLD 2015-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207947-002 UPTRAVI 0.4MG TABLET / ORAL AB RLD, RS 2015-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207947-003 UPTRAVI 0.6MG TABLET / ORAL AB RLD 2015-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207947-004 UPTRAVI 0.8MG TABLET / ORAL AB RLD 2015-12-21 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 154 observed states.
Observed Orange Book patent history# Patent history page 1 of 57 · 2,248 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N207947-001 7205302 2026-10-31 U-1797 Drug substance, Drug product 2016-01-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-001 7205302*PED 2027-04-30 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-001 9173881 2029-08-12 U-1798 2016-01-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-001 9173881*PED 2030-02-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-001 9284280 2030-06-25 U-1831 2016-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-001 8791122 2030-08-01 Drug substance, Drug product 2016-01-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-001 9284280*PED 2030-12-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-001 8791122*PED 2031-02-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-001 10821108 2036-12-01 U-2992 Drug product 2020-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-001 10828298 2036-12-01 U-2991 Drug product 2020-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-001 10821108*PED 2037-06-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-001 10828298*PED 2037-06-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 7205302 2026-10-31 U-1797 Drug substance, Drug product 2016-01-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 7205302*PED 2027-04-30 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 9173881 2029-08-12 U-1798 2016-01-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 9173881*PED 2030-02-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 9284280 2030-06-25 U-1831 2016-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 8791122 2030-08-01 Drug substance, Drug product 2016-01-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 9284280*PED 2030-12-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 8791122*PED 2031-02-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 10821108 2036-12-01 U-2992 Drug product 2020-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 10828298 2036-12-01 U-2991 Drug product 2020-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 10821108*PED 2037-06-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-002 10828298*PED 2037-06-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 7205302 2026-10-31 U-1797 Drug substance, Drug product 2016-01-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 7205302*PED 2027-04-30 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 9173881 2029-08-12 U-1798 2016-01-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 9173881*PED 2030-02-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 9284280 2030-06-25 U-1831 2016-04-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 8791122 2030-08-01 Drug substance, Drug product 2016-01-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 9284280*PED 2030-12-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 8791122*PED 2031-02-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 10821108 2036-12-01 U-2992 Drug product 2020-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 10828298 2036-12-01 U-2991 Drug product 2020-12-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 10821108*PED 2037-06-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-003 10828298*PED 2037-06-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-004 7205302 2026-10-31 U-1797 Drug substance, Drug product 2016-01-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-004 7205302*PED 2027-04-30 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-004 9173881 2029-08-12 U-1798 2016-01-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207947-004 9173881*PED 2030-02-12 Pediatric extension 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 252 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 2 of 2 · 101 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66215-616 UPTRAVI Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-616 UPTRAVI Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-616 UPTRAVI Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-616 UPTRAVI Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-616 UPTRAVI Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-616 UPTRAVI Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-616 UPTRAVI Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-616 UPTRAVI Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-628 UPTRAVI Titration Pack Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-628 UPTRAVI Titration Pack Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-628 UPTRAVI Titration Pack Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-628 UPTRAVI Titration Pack Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-628 UPTRAVI Titration Pack Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-628 UPTRAVI Titration Pack Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-628 UPTRAVI Titration Pack Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-628 UPTRAVI Titration Pack Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-628 UPTRAVI Titration Pack Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-628 UPTRAVI Titration Pack Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-628 UPTRAVI Titration Pack Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-718 UPTRAVI Selexipag Actelion Pharmaceuticals US, Inc. NDA Current 66215-718 UPTRAVI Selexipag Actelion Pharmaceuticals US, Inc. NDA Current