Application 211224

Type: ANDA
Sponsor: ZYDUS WORLDWIDE DMCC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MACITENTAN	MACITENTAN	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211224-001	MACITENTAN	MACITENTAN	10MG	TABLET / ORAL	AB		2021-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211224-001	AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A211224-001	PC	2026-12-03

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211224-001	MACITENTAN	10MG	TABLET / ORAL	AB	2021-04-06	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211224-001	MACITENTAN	10MG	TABLET / ORAL		2021-04-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211224-001	MACITENTAN	10MG	TABLET / ORAL	AB	2021-04-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211224-001	AB	1	`87673890dc5c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211224-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211224-001	PC	2026-12-03	`a50c72e98297…`

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
MACITENTAN	MACITENTAN	Zydus Pharmaceuticals USA Inc.	39ed1c20-99ae-4780-b040-dbebfc90018f	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211224 application number: ANDA211224

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76512	ORIG	2023-11-07
67403	ORIG	2021-05-05