Application 216208

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	No	No
002	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216208-001	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2026-02-18
A216208-002	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL			2026-02-18

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	A216208-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2026-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216208-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL		2026-02-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216208-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216208-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-02-18	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216208-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-02-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216208-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-02-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216208-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216208-002	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216208-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216208-002	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
Aripiprazole	ARIPIPRAZOLE	Aurobindo Pharma Limited	476b92f3-cf7b-4c09-ac67-6ed35e6811d5	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216208 application number: ANDA216208

Reported adverse events (FAERS/openFDA)#

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