Application 212496

Type: ANDA
Sponsor: WILSHIRE PHARMS INC

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212496-001	DOFETILIDE	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2026-07-29
A212496-002	DOFETILIDE	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2026-07-29
A212496-003	DOFETILIDE	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2026-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212496-001	AB
A212496-002	AB
A212496-003	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	A212496-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2026-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212496-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2026-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212496-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2026-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212496-001	DOFETILIDE	0.125MG	CAPSULE / ORAL	AB	2026-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212496-002	DOFETILIDE	0.25MG	CAPSULE / ORAL	AB	2026-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212496-003	DOFETILIDE	0.5MG	CAPSULE / ORAL	AB	2026-07-29	`caaa826d4ba7…`

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	A212496-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212496-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212496-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212496-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212496-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212496-003	AB	1	`caaa826d4ba7…`

Reported adverse events (FAERS/openFDA)#

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