Application 205080

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ITRACONAZOLE	ITRACONAZOLE	CAPSULE;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
A205080-001	ITRACONAZOLE	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB		2016-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205080-001	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.

Product history page 1 of 2 · 42 observed 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	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205080-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2016-09-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205080-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205080-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205080-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205080-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205080-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205080-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205080-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205080-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205080-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205080-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205080-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205080-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205080-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205080-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205080-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205080-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205080-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205080-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205080-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205080-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205080-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205080-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205080-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205080-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205080-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205080-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205080-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205080-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205080-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205080-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205080-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205080-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205080-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205080-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205080-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205080-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205080-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205080-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205080-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205080-001	AB	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Itraconazole	ITRACONAZOLE	Amneal Pharmaceuticals LLC	2ab38a8a-3708-4b97-9f7f-8e554a15348d	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205080 application number: ANDA205080 ndc (product): 65162-630
Itraconazole	ITRACONAZOLE	AvPAK	68165d90-953c-e2f5-e053-2a91aa0ada25	2026-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205080 application number: ANDA205080 ndc (product): 50268-450
Itraconazole	ITRACONAZOLE	American Health Packaging	e564067e-e469-4c51-9076-75f89f5c5cdf	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205080 application number: ANDA205080 ndc (product): 60687-299

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50268-450	Itraconazole	Itraconazole	AvPAK	ANDA	Current
50268-450	Itraconazole	Itraconazole	AvPAK	ANDA	Current
50268-450	Itraconazole	Itraconazole	AvPAK	ANDA	Current
60687-299	Itraconazole	Itraconazole	American Health Packaging	ANDA	Current
60687-299	Itraconazole	Itraconazole	American Health Packaging	ANDA	Current
60687-299	Itraconazole	Itraconazole	American Health Packaging	ANDA	Current
60687-299	Itraconazole	Itraconazole	American Health Packaging	ANDA	Current
60687-299	Itraconazole	Itraconazole	American Health Packaging	ANDA	Current
65162-630	Itraconazole	Itraconazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-630	Itraconazole	Itraconazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-630	Itraconazole	Itraconazole	Amneal Pharmaceuticals LL	ANDA	Current
65162-630	Itraconazole	Itraconazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-630	Itraconazole	Itraconazole	Amneal Pharmaceuticals LLC	ANDA	Current