Application 076479

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ECONAZOLE NITRATE	ECONAZOLE NITRATE	CREAM;TOPICAL	1%	No	Yes

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
A076479-001	ECONAZOLE NITRATE	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076479-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076479-001	ECONAZOLE NITRATE	1%	CREAM / TOPICAL	AB	RS	2004-06-23	`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	A076479-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076479-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076479-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076479-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076479-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076479-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076479-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076479-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076479-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076479-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076479-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076479-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076479-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076479-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076479-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076479-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076479-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076479-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076479-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076479-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076479-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076479-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076479-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076479-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076479-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076479-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076479-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076479-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076479-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076479-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076479-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076479-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076479-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076479-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076479-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076479-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076479-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076479-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076479-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076479-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Econazole Nitrate	ECONAZOLE NITRATE	Bryant Ranch Prepack	790a86cc-e93b-4bb6-9b60-08b2c4587081	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479
Econazole Nitrate	ECONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	caa348ad-4832-435f-844d-55831f235cc0	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479 ndc (product): 68788-8170
Econazole Nitrate	ECONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	2bd2a48e-cbef-4b14-a02f-9aa693cc4b47	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479
Econazole Nitrate	ECONAZOLE NITRATE	Bryant Ranch Prepack	b0c90efd-d9a2-4120-aa17-33a9d50f7347	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479 ndc (product): 63629-8645
Econazole Nitrate	ECONAZOLE NITRATE	Bryant Ranch Prepack	ae173340-7611-4dc8-99a7-7669bc4fc97d	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479 ndc (product): 63629-8647
Econazole Nitrate	ECONAZOLE NITRATE	Bryant Ranch Prepack	4ac65707-a8b2-45de-a3c6-89e3ea845124	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479 ndc (product): 63629-8646
Econazole Nitrate	ECONAZOLE NITRATE	Padagis Israel Pharmaceuticals Ltd	3acc5e03-0339-4b23-945d-641746e81923	2023-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076479 application number: ANDA076479 ndc (product): 45802-466

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-892	Econazole Nitrate	Econazole Nitrate	Rebel Distributors Corp	ANDA	Current
45802-466	Econazole Nitrate	Econazole Nitrate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-466	Econazole Nitrate	Econazole Nitrate	Perrigo New York Inc	ANDA	Current
45802-466	Econazole Nitrate	Econazole Nitrate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
63629-8645	Econazole Nitrate	Econazole Nitrate	Bryant Ranch Prepack	ANDA	Current
63629-8645	Econazole Nitrate	Econazole Nitrate	Bryant Ranch Prepack	ANDA	Current
63629-8645	Econazole Nitrate	Econazole Nitrate	Bryant Ranch Prepack	ANDA	Current
63629-8645	Econazole Nitrate	Econazole Nitrate	Bryant Ranch Prepack	ANDA	Current
63629-8646	Econazole Nitrate	Econazole Nitrate	Bryant Ranch Prepack	ANDA	Current
63629-8646	Econazole Nitrate	Econazole Nitrate	Bryant Ranch Prepack	ANDA	Current
63629-8646	Econazole Nitrate	Econazole Nitrate	Bryant Ranch Prepack	ANDA	Current
63629-8646	Econazole Nitrate	Econazole Nitrate	Bryant Ranch Prepack	ANDA	Current
63629-8647	Econazole Nitrate	Econazole Nitrate	Bryant Ranch Prepack	ANDA	Current
63629-8647	Econazole Nitrate	Econazole Nitrate	Bryant Ranch Prepack	ANDA	Current
63629-8647	Econazole Nitrate	Econazole Nitrate	Bryant Ranch Prepack	ANDA	Current
63629-8647	Econazole Nitrate	Econazole Nitrate	Bryant Ranch Prepack	ANDA	Current
68788-8170	Econazole Nitrate	Econazole Nitrate	Preferred Pharmaceuticals Inc.	ANDA	Current