Application 211128

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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 43.

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
A211128-001	MACITENTAN	MACITENTAN	10MG	TABLET / ORAL	AB		2025-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211128-001	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.

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	A211128-001	MACITENTAN	10MG	TABLET / ORAL	AB	2025-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211128-001	MACITENTAN	10MG	TABLET / ORAL	AB	2025-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211128-001	MACITENTAN	10MG	TABLET / ORAL	AB	2025-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211128-001	MACITENTAN	10MG	TABLET / ORAL	AB	2025-08-18	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211128-001	MACITENTAN	10MG	TABLET / ORAL	AB	2025-08-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211128-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211128-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211128-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211128-001	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211128-001	AB	1	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Macitentan	MACITENTAN	Alembic Pharmaceuticals Limited	4d9d9a84-6853-4004-b20a-8849b34453a4	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211128 application number: ANDA211128
Macitentan	MACITENTAN	Alembic Pharmaceuticals Inc.	98b3309a-5012-42b5-b773-a38c2f52296c	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211128 application number: ANDA211128

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
83163	ORIG	2025-08-21