Application 076090

Type: ANDA
Sponsor: PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PERMETHRIN	PERMETHRIN	LOTION;TOPICAL	1%	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
A076090-001	PERMETHRIN	PERMETHRIN	1%	LOTION / TOPICAL			2001-12-20

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense lice killing creme rinse	PERMETHRIN	L. Perrigo Company	056fb377-34dd-4d33-83d7-c895b105f574	2022-11-21	Warnings	Exact identifier application applno (ANDA): 076090 application number: ANDA076090 ndc (product): 0113-1910
Topcare lice killing creme rinse	PERMETHRIN	Topco Associates LLC	3b4146a6-7c54-4dd0-9388-1e38491d16f3	2020-01-31	Warnings	Exact identifier application applno (ANDA): 076090 application number: ANDA076090 ndc (product): 36800-629

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-1910	good sense lice killing creme rinse	Permethrin	L. Perrigo Company	ANDA	Current
0113-1910	good sense lice killing creme rinse	Permethrin	L. Perrigo Company	ANDA	Current
0363-0955	lice treatment	Permethrin	Walgreen Company	ANDA	Current
0363-0955	lice treatment	Permethrin	Walgreen Company	ANDA	Current
0363-0955	lice treatment	Permethrin	Walgreen Company	ANDA	Current
11822-0549	lice treatment	Permethrin	Rite Aid Corporation	ANDA	Current
36800-629	Topcare lice killing creme rinse	Permethrin	Topco Associates LLC	ANDA	Current
36800-955	topcare lice treatment	Permethrin	Topco Associates LLC	ANDA	Current
42507-955	lice treatment	Permethrin	HyVee Inc	ANDA	Current
46122-108	good neighbor pharmacy lice treatment	Permethrin	Amerisource Bergen	ANDA	Current
49348-150	sunmark lice treatment	Permethrin	Strategic Sourcing Services LLC	ANDA	Current
49348-150	sunmark lice treatment	Permethrin	Strategic Sourcing Services LLC	ANDA	Current
49348-150	sunmark lice treatment	Permethrin	Mckesson	ANDA	Current
49781-028	leader lice treatment	Permethrin	Cardinal Health	ANDA	Current
49781-028	leader lice treatment	Permethrin	Cardinal Health	ANDA	Current
50090-3478	sunmark lice treatment	Permethrin	A-S Medication Solutions	ANDA	Current
59779-769	Lice Treatment	Permethrin	CVS Pharmacy	ANDA	Current
62011-0255	health mart lice treatment	Permethrin	McKesson	ANDA	Current
62011-0255	health mart lice treatment	Permethrin	Strategic Sourcing Services LLC	ANDA	Current
62011-0255	health mart lice treatment	Permethrin	Strategic Sourcing Services LLC	ANDA	Current
70000-0041	leader lice treatment	Permethrin	Cardinal Health	ANDA	Current
70000-0041	leader lice treatment	Permethrin	Cardinal Health	ANDA	Current
70000-0041	leader lice treatment	Permethrin	Cardinal Health 110, LLC. dba Leader	ANDA	Current
76413-320	Permethrin	Permethrin	Central Texas Community Health Centers	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22534	ORIG	2005-07-22