Application 216626

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POSACONAZOLE	POSACONAZOLE	TABLET, DELAYED RELEASE;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A216626-001	POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2022-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216626-001	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
2026-08-18 06:07:40	2026-07	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216626-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-12-22	`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	A216626-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216626-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216626-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216626-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216626-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216626-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216626-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216626-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216626-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216626-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216626-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216626-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216626-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216626-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216626-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216626-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216626-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216626-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216626-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216626-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216626-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216626-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216626-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216626-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216626-001	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
Posaconazole	POSACONAZOLE	Amneal Pharmaceuticals NY LLC	5f795eca-7a03-4c91-9a0e-c1235791b665	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216626 application number: ANDA216626
Posaconazole	POSACONAZOLE	AvKARE	f9c81d88-8e2c-fa53-e053-6394a90ac5c4	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216626 application number: ANDA216626