Application 215399

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDOMETHACIN	INDOMETHACIN	SUPPOSITORY;RECTAL	50MG	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
A215399-001	INDOMETHACIN	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB		2025-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215399-001	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
2026-02-19 14:30 UTC	2026-02	A215399-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	2025-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215399-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	2025-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215399-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	2025-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215399-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	2025-02-24	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215399-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	2025-02-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215399-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215399-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215399-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215399-001	AB	1	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215399-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	Amneal Pharmaceuticals NY LLC	8b48d2b3-61b5-4cfc-a8a0-7ccc235dfe5a	2024-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215399 application number: ANDA215399