Application 214414

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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	0.4MG	No	No
003	SELEXIPAG	SELEXIPAG	TABLET;ORAL	0.6MG	No	No
004	SELEXIPAG	SELEXIPAG	TABLET;ORAL	0.8MG	No	No
005	SELEXIPAG	SELEXIPAG	TABLET;ORAL	1.4MG	No	No
006	SELEXIPAG	SELEXIPAG	TABLET;ORAL	1.6MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214414-001	SELEXIPAG	SELEXIPAG	0.2MG	TABLET / ORAL	AB	2023-10-11
A214414-002	SELEXIPAG	SELEXIPAG	0.4MG	TABLET / ORAL	AB	2023-10-11
A214414-003	SELEXIPAG	SELEXIPAG	0.6MG	TABLET / ORAL	AB	2023-10-11
A214414-004	SELEXIPAG	SELEXIPAG	0.8MG	TABLET / ORAL	AB	2023-10-11
A214414-005	SELEXIPAG	SELEXIPAG	1.4MG	TABLET / ORAL	AB	2023-10-11
A214414-006	SELEXIPAG	SELEXIPAG	1.6MG	TABLET / ORAL	AB	2023-10-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A214414-001	AB
A214414-002	AB
A214414-003	AB
A214414-004	AB
A214414-005	AB
A214414-006	AB

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214414-001	SELEXIPAG	0.2MG	TABLET / ORAL	AB	2023-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214414-002	SELEXIPAG	0.4MG	TABLET / ORAL	AB	2023-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214414-003	SELEXIPAG	0.6MG	TABLET / ORAL	AB	2023-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214414-004	SELEXIPAG	0.8MG	TABLET / ORAL	AB	2023-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214414-005	SELEXIPAG	1.4MG	TABLET / ORAL	AB	2023-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214414-006	SELEXIPAG	1.6MG	TABLET / ORAL	AB	2023-10-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214414-001	SELEXIPAG	0.2MG	TABLET / ORAL	AB	2023-10-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214414-002	SELEXIPAG	0.4MG	TABLET / ORAL	AB	2023-10-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214414-003	SELEXIPAG	0.6MG	TABLET / ORAL	AB	2023-10-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214414-004	SELEXIPAG	0.8MG	TABLET / ORAL	AB	2023-10-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214414-005	SELEXIPAG	1.4MG	TABLET / ORAL	AB	2023-10-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214414-006	SELEXIPAG	1.6MG	TABLET / ORAL	AB	2023-10-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214414-001	SELEXIPAG	0.2MG	TABLET / ORAL	AB	2023-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214414-002	SELEXIPAG	0.4MG	TABLET / ORAL	AB	2023-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214414-003	SELEXIPAG	0.6MG	TABLET / ORAL	AB	2023-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214414-004	SELEXIPAG	0.8MG	TABLET / ORAL	AB	2023-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214414-005	SELEXIPAG	1.4MG	TABLET / ORAL	AB	2023-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214414-006	SELEXIPAG	1.6MG	TABLET / ORAL	AB	2023-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214414-001	SELEXIPAG	0.2MG	TABLET / ORAL	AB	2023-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214414-002	SELEXIPAG	0.4MG	TABLET / ORAL	AB	2023-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214414-003	SELEXIPAG	0.6MG	TABLET / ORAL	AB	2023-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214414-004	SELEXIPAG	0.8MG	TABLET / ORAL	AB	2023-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214414-005	SELEXIPAG	1.4MG	TABLET / ORAL	AB	2023-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214414-006	SELEXIPAG	1.6MG	TABLET / ORAL	AB	2023-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214414-001	SELEXIPAG	0.2MG	TABLET / ORAL	AB	2023-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214414-002	SELEXIPAG	0.4MG	TABLET / ORAL	AB	2023-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214414-003	SELEXIPAG	0.6MG	TABLET / ORAL	AB	2023-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214414-004	SELEXIPAG	0.8MG	TABLET / ORAL	AB	2023-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214414-005	SELEXIPAG	1.4MG	TABLET / ORAL	AB	2023-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214414-006	SELEXIPAG	1.6MG	TABLET / ORAL	AB	2023-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214414-001	SELEXIPAG	0.2MG	TABLET / ORAL	AB	2023-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214414-002	SELEXIPAG	0.4MG	TABLET / ORAL	AB	2023-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214414-003	SELEXIPAG	0.6MG	TABLET / ORAL	AB	2023-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214414-004	SELEXIPAG	0.8MG	TABLET / ORAL	AB	2023-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214414-005	SELEXIPAG	1.4MG	TABLET / ORAL	AB	2023-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214414-006	SELEXIPAG	1.6MG	TABLET / ORAL	AB	2023-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214414-001	SELEXIPAG	0.2MG	TABLET / ORAL	AB	2023-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214414-002	SELEXIPAG	0.4MG	TABLET / ORAL	AB	2023-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214414-003	SELEXIPAG	0.6MG	TABLET / ORAL	AB	2023-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214414-004	SELEXIPAG	0.8MG	TABLET / ORAL	AB	2023-10-11	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214414-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214414-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214414-005	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214414-006	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214414-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214414-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214414-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214414-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214414-005	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214414-006	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214414-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214414-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214414-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214414-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214414-005	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214414-006	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214414-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214414-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214414-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214414-004	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214414-005	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214414-006	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214414-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214414-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214414-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214414-004	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214414-005	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214414-006	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214414-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214414-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214414-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214414-004	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214414-005	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214414-006	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214414-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214414-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214414-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214414-004	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214414-005	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214414-006	AB	1	`a72a2bbeb626…`

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 · 3 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
Selexipag	SELEXIPAG	Zydus Lifesciences Limited	ff660787-880f-4f2b-baac-fd2dbfcd79c2	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Selexipag generic name: SELEXIPAG
Selexipag	SELEXIPAG	Zydus Pharmaceuticals (USA) Inc.	c604e181-e336-4194-bf96-f65dd164d461	2024-05-25	Warnings, Adverse reactions	Name fallback brand name: Selexipag 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
69857	ORIG	2022-01-12