Application 214302

Type: ANDA
Sponsor: ZYDUS WORLDWIDE DMCC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SELEXIPAG	SELEXIPAG	TABLET;ORAL	0.2MG	No	No
002	SELEXIPAG	SELEXIPAG	TABLET;ORAL	400MCG	No	No
003	SELEXIPAG	SELEXIPAG	TABLET;ORAL	600MCG	No	No
004	SELEXIPAG	SELEXIPAG	TABLET;ORAL	800MCG	No	No
005	SELEXIPAG	SELEXIPAG	TABLET;ORAL	1000MC	No	No
006	SELEXIPAG	SELEXIPAG	TABLET;ORAL	1200MCG	No	No
007	SELEXIPAG	SELEXIPAG	TABLET;ORAL	1400MCG	No	No
008	SELEXIPAG	SELEXIPAG	TABLET;ORAL	1600MCG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A214302-001	SELEXIPAG	SELEXIPAG	0.2MG	TABLET / ORAL	2022-12-21
A214302-002	SELEXIPAG	SELEXIPAG	0.4MG	TABLET / ORAL	2022-12-21
A214302-003	SELEXIPAG	SELEXIPAG	0.6MG	TABLET / ORAL	2022-12-21
A214302-004	SELEXIPAG	SELEXIPAG	0.8MG	TABLET / ORAL	2022-12-21
A214302-005	SELEXIPAG	SELEXIPAG	1MG	TABLET / ORAL	2022-12-21
A214302-006	SELEXIPAG	SELEXIPAG	1.2MG	TABLET / ORAL	2022-12-21
A214302-007	SELEXIPAG	SELEXIPAG	1.4MG	TABLET / ORAL	2022-12-21
A214302-008	SELEXIPAG	SELEXIPAG	1.6MG	TABLET / ORAL	2022-12-21

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 6 · 216 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A214302-001	SELEXIPAG	0.2MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-002	SELEXIPAG	0.4MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-003	SELEXIPAG	0.6MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-004	SELEXIPAG	0.8MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-005	SELEXIPAG	1MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-006	SELEXIPAG	1.2MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-007	SELEXIPAG	1.4MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214302-008	SELEXIPAG	1.6MG	TABLET / ORAL	2022-12-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214302-001	SELEXIPAG	0.2MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-002	SELEXIPAG	0.4MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-003	SELEXIPAG	0.6MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-004	SELEXIPAG	0.8MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-005	SELEXIPAG	1MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-006	SELEXIPAG	1.2MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-007	SELEXIPAG	1.4MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214302-008	SELEXIPAG	1.6MG	TABLET / ORAL	2022-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214302-001	SELEXIPAG	0.2MG	TABLET / ORAL	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214302-002	SELEXIPAG	0.4MG	TABLET / ORAL	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214302-003	SELEXIPAG	0.6MG	TABLET / ORAL	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214302-004	SELEXIPAG	0.8MG	TABLET / ORAL	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214302-005	SELEXIPAG	1MG	TABLET / ORAL	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214302-006	SELEXIPAG	1.2MG	TABLET / ORAL	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214302-007	SELEXIPAG	1.4MG	TABLET / ORAL	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214302-008	SELEXIPAG	1.6MG	TABLET / ORAL	2022-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214302-001	SELEXIPAG	0.2MG	TABLET / ORAL	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214302-002	SELEXIPAG	0.4MG	TABLET / ORAL	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214302-003	SELEXIPAG	0.6MG	TABLET / ORAL	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214302-004	SELEXIPAG	0.8MG	TABLET / ORAL	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214302-005	SELEXIPAG	1MG	TABLET / ORAL	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214302-006	SELEXIPAG	1.2MG	TABLET / ORAL	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214302-007	SELEXIPAG	1.4MG	TABLET / ORAL	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214302-008	SELEXIPAG	1.6MG	TABLET / ORAL	2022-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214302-001	SELEXIPAG	0.2MG	TABLET / ORAL	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214302-002	SELEXIPAG	0.4MG	TABLET / ORAL	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214302-003	SELEXIPAG	0.6MG	TABLET / ORAL	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214302-004	SELEXIPAG	0.8MG	TABLET / ORAL	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214302-005	SELEXIPAG	1MG	TABLET / ORAL	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214302-006	SELEXIPAG	1.2MG	TABLET / ORAL	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214302-007	SELEXIPAG	1.4MG	TABLET / ORAL	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214302-008	SELEXIPAG	1.6MG	TABLET / ORAL	2022-12-21	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A214302-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-004	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-005	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-006	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-007	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214302-008	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214302-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-004	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-005	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-006	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-007	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214302-008	AB	1	`3bdfa0b2c4d7…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UPTRAVI	SELEXIPAG	Actelion Pharmaceuticals US, Inc.	a7a23b87-f892-4e2c-8e2e-ebf841220f90	2026-05-28	Warnings, Adverse reactions	Name fallback generic name: SELEXIPAG

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73131	ORIG	2023-01-10
71880	ORIG	2022-08-25