Application 208979

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALBENDAZOLE	ALBENDAZOLE	TABLET;ORAL	200MG	No	No

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
A208979-001	ALBENDAZOLE	ALBENDAZOLE	200MG	TABLET / ORAL	AB		2018-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208979-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208979-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2018-12-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208979-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208979-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208979-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208979-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208979-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208979-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208979-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208979-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208979-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208979-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208979-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208979-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208979-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208979-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208979-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208979-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208979-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208979-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208979-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208979-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208979-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208979-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208979-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208979-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208979-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208979-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208979-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208979-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208979-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208979-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208979-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208979-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208979-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208979-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208979-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208979-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208979-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208979-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208979-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208979-001	AB	1	`cb3db0bc1861…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Albendazole	ALBENDAZOLE	Edenbridge Pharmaceuticals LLC.	6c48fd89-cb40-477c-8a78-15cbe0df6faa	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Albendazole generic name: ALBENDAZOLE
Albendazole	ALBENDAZOLE	Golden State Medical Supply, Inc.	8de337eb-92e1-15b5-e053-2a95a90ac4f1	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Albendazole generic name: ALBENDAZOLE
Albendazole	ALBENDAZOLE	Alembic Pharmaceuticals Limited	3b4945c7-56e9-47ed-a7ac-5078a1a50b85	2024-09-13	Warnings, Adverse reactions	Name fallback brand name: Albendazole generic name: ALBENDAZOLE
Albendazole	ALBENDAZOLE	Alembic Pharmaceuticals Inc.	2d6856a3-583e-41d4-b73d-6867cbb9778c	2024-09-11	Warnings, Adverse reactions	Name fallback brand name: Albendazole generic name: ALBENDAZOLE
Albendazole	ALBENDAZOLE	Bryant Ranch Prepack	74aeb307-b408-47b1-bd8f-fe7eeb844466	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Albendazole generic name: ALBENDAZOLE
Albendazole	ALBENDAZOLE	Dr.Reddys Laboratories Inc	9ac95554-94c9-1f38-8f49-ec11979e4ba4	2020-06-10	Warnings, Adverse reactions	Name fallback brand name: Albendazole generic name: ALBENDAZOLE
Albendazole	ALBENDAZOLE	Novadoz Pharmaceuticals LLC	594f7aab-b336-4d6d-b702-a33346c69645	2020-02-01	Warnings, Adverse reactions	Name fallback brand name: Albendazole generic name: ALBENDAZOLE
Albendazole	ALBENDAZOLE	Amneal Pharmaceuticals of New York LLC	06b5eefc-0b95-4862-b9b6-770063f2adf0	2019-09-30	Warnings, Adverse reactions	Name fallback brand name: Albendazole generic name: ALBENDAZOLE
ALBENZA	ALBENDAZOLE	Amneal Pharmaceuticals LLC	1977a867-0ee1-44c0-8da3-fe59c48699f5	2019-09-23	Warnings, Adverse reactions	Name fallback generic name: ALBENDAZOLE
Albendazole	ALBENDAZOLE	Actavis Pharma, Inc.	f5c7b8cb-a81f-4b13-b3c4-f6edaf880d3b	2019-07-31	Warnings, Adverse reactions	Name fallback brand name: Albendazole generic name: ALBENDAZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-907	Albendazole	Albendazole	Northstar Rx LLC.	ANDA	Current
16714-907	Albendazole	Albendazole	Northstar Rx LLC.	ANDA	Current
16714-907	Albendazole	Albendazole	Northstar Rx LLC.	ANDA	Current
16714-907	Albendazole	Albendazole	Northstar Rx LLC.	ANDA	Current
70710-1021	Albendazole	Albendazole	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1021	Albendazole	Albendazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1021	Albendazole	Albendazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1021	Albendazole	Albendazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1103	Albendazole	Albendazole	Cadila Healthcare Limited	ANDA	Current
70771-1103	Albendazole	Albendazole	Zydus Lifesciences Limited	ANDA	Current
70771-1103	Albendazole	Albendazole	Cadila Healthcare Limited	ANDA	Current
70771-1103	Albendazole	Albendazole	Cadila Healthcare Limited	ANDA	Current