Application 020666

Type: NDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALBENZA	ALBENDAZOLE	TABLET;ORAL	200MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020666-001	ALBENZA	ALBENDAZOLE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020666-001	ALBENZA	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-06-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020666-001	ALBENZA	200MG	TABLET / ORAL	AB	RLD, RS	1996-06-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020666-001	ALBENZA	200MG	TABLET / ORAL		RLD	1996-06-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020666-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020666-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020666-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020666-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020666-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020666-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020666-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020666-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020666-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020666-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020666-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020666-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020666-001	AB	1	`ea99ee380514…`

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
Albendazole	ALBENDAZOLE	Amneal Pharmaceuticals of New York LLC	06b5eefc-0b95-4862-b9b6-770063f2adf0	2019-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020666 application number: NDA020666 ndc (product): 0115-1701
ALBENZA	ALBENDAZOLE	Amneal Pharmaceuticals LLC	1977a867-0ee1-44c0-8da3-fe59c48699f5	2019-09-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020666 application number: NDA020666 ndc (product): 64896-693

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1701	Albendazole	albendazole	Impax Generics	NDA	Current
0115-1701	Albendazole	albendazole	Amneal Pharmaceuticals of New York LLC	NDA	Current
0115-1701	Albendazole	albendazole	Amneal Pharmaceuticals of New York LLC	NDA	Current
0115-1701	Albendazole	albendazole	Amneal Pharmaceuticals of New York LLC	NDA	Current
0115-1701	Albendazole	albendazole	Amneal Pharmaceuticals of New York LLC	NDA	Current
0115-1701	Albendazole	albendazole	Amneal Pharmaceuticals of New York LLC	NDA	Current
52054-550	ALBENZA	albendazole	Amedra Pharmaceuticals LLC	NDA	Current
54505-055	Albendazole	Albendazole	Lineage Therapeutics Inc	NDA	Current
54505-055	Albendazole	Albendazole	Lineage Therapeutics Inc	NDA	Current
54505-055	Albendazole	Albendazole	Lineage Therapeutics Inc	NDA	Current
55695-021	ALBENZA	albendazole	Department of State Health Services, Pharmacy Branch	NDA	Current
64896-693	ALBENZA	albendazole	Amneal Pharmaceuticals LLC	NDA	Current
64896-693	ALBENZA	albendazole	Amneal Pharmaceuticals LLC	NDA	Current
64896-693	ALBENZA	albendazole	Amneal Pharmaceuticals LLC	NDA	Current
64896-693	ALBENZA	albendazole	Amneal Pharmaceuticals LLC	NDA	Current
64896-693	ALBENZA	albendazole	Impax Specialty Pharma	NDA	Current
64896-693	ALBENZA	albendazole	Amneal Pharmaceuticals LLC	NDA	Current
65084-462	ALBENZA	albendazole	Mckesson Rxpak Inc	NDA	Current
76413-145	ALBENZA	albendazole	Central Texas Community Health Centers	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59323	SUPPL	2019-07-12
59318	SUPPL	2019-07-12
57684	ORIG	2019-02-15
57046	SUPPL	2018-12-28
56218	SUPPL	2018-10-31
50888	SUPPL	2017-12-27
50846	SUPPL	2017-12-22
12952	SUPPL	2015-06-12
3037	SUPPL	2015-06-12
25472	SUPPL	2009-11-19
3036	SUPPL	2009-11-19
35111	SUPPL	2009-10-21
35110	SUPPL	2009-10-21
3035	SUPPL	2007-08-22
35109	SUPPL	2007-08-21