Application 076369

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PERMETHRIN	PERMETHRIN	CREAM;TOPICAL	5%	No	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
A076369-001	PERMETHRIN	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076369-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB		2003-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB		2003-04-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB		2003-04-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB		2003-04-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076369-001	PERMETHRIN	5%	CREAM / TOPICAL	AB	RS	2003-04-21	`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	A076369-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076369-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076369-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076369-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076369-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076369-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076369-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076369-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076369-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076369-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076369-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076369-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076369-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076369-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076369-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076369-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076369-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076369-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076369-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076369-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076369-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076369-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076369-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076369-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076369-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076369-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076369-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076369-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076369-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076369-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076369-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076369-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076369-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076369-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076369-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076369-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076369-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076369-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076369-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076369-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Permethrin	PERMETHRIN	Bryant Ranch Prepack	850414a5-a261-40ac-999e-cdcbd23c0cb0	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076369 application number: ANDA076369
Permethrin	PERMETHRIN	Bryant Ranch Prepack	f4af5093-2e4a-43c6-b585-4bb14f73f370	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076369 application number: ANDA076369
Permethrin	PERMETHRIN	Northstar Rx LLC	11e91140-cf12-42de-9f4a-cdbc22e74658	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076369 application number: ANDA076369 ndc (product): 16714-897
Permethrin	PERMETHRIN	Padagis Israel Pharmaceuticals Ltd	bdb796aa-a7d1-4476-988f-2b4a9519788f	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076369 application number: ANDA076369 ndc (product): 45802-269

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
16714-897	Permethrin	Permethrin	Northstar RxLLC	ANDA	Current
16714-897	Permethrin	Permethrin	Northstar Rx LLC	ANDA	Current
16714-897	Permethrin	Permethrin	Northstar RxLLC	ANDA	Current
21695-907	Permethrin	Permethrin	Rebel Distributors Corp	ANDA	Current
45802-269	Permethrin	Permethrin	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-269	Permethrin	Permethrin	Perrigo New York Inc	ANDA	Current
45802-269	Permethrin	Permethrin	Perrigo New York Inc	ANDA	Current
50090-3149	Permethrin	Permethrin	A-S Medication Solutions	ANDA	Current
50090-3149	Permethrin	Permethrin	A-S Medication Solutions	ANDA	Current
50090-3149	Permethrin	Permethrin	A-S Medication Solutions	ANDA	Current
50090-3149	Permethrin	Permethrin	A-S Medication Solutions	ANDA	Current
52959-159	Permethrin	Permethrin	H.J. Harkins Company, Inc.	ANDA	Current
53002-9570	Permethrin	Permethrin	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9570	Permethrin	Permethrin	RPK Pharmaceuticals, Inc.	ANDA	Current
68071-3294	Permethrin	Permethrin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3316	Permethrin	Permethrin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3316	Permethrin	Permethrin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3316	Permethrin	Permethrin	NuCare Pharmaceuticals,Inc.	ANDA	Current
76413-122	Permethrin	Permethrin	Central Texas Community Health Centers	ANDA	Current