Application 208591

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A208591-001	ITRACONAZOLE	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB		2017-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208591-001	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	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208591-001	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	2017-06-12	`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	A208591-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208591-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208591-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208591-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208591-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208591-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208591-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208591-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208591-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208591-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208591-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208591-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208591-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208591-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208591-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208591-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208591-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208591-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208591-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208591-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208591-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208591-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208591-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208591-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208591-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208591-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208591-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208591-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208591-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208591-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208591-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208591-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208591-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208591-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208591-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208591-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208591-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208591-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208591-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208591-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Itraconazole	ITRACONAZOLE	Ascend Laboratories, LLC	349ffcf4-b2cd-4c93-9411-13c39275b8f3	2025-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208591 application number: ANDA208591 ndc (product): 67877-454
Itraconazole	ITRACONAZOLE	NorthStar RxLLC	46732a10-1f0d-4022-9689-256c44683e96	2023-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208591 application number: ANDA208591 ndc (product): 16714-743

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-743	Itraconazole	Itraconazole	NorthStar RxLLC	ANDA	Current
16714-743	Itraconazole	Itraconazole	NorthStar RxLLC	ANDA	Current
16714-743	Itraconazole	Itraconazole	NorthStar RxLLC	ANDA	Current
63629-8168	Itraconazole	Itraconazole	Bryant Ranch Prepack	ANDA	Current
63629-8168	Itraconazole	Itraconazole	Bryant Ranch Prepack	ANDA	Current
67877-454	Itraconazole	Itraconazole	Ascend Laboratories, LLC	ANDA	Current
67877-454	Itraconazole	Itraconazole	Ascend Laboratories, LLC	ANDA	Current
67877-454	Itraconazole	Itraconazole	Ascend Laboratories, LLC	ANDA	Current
67877-454	Itraconazole	Itraconazole	Ascend Laboratories, LLC	ANDA	Current
70518-2872	Itraconazole	Itraconazole	REMEDYREPACK INC.	ANDA	Current
70518-2872	Itraconazole	Itraconazole	REMEDYREPACK INC.	ANDA	Current