Application 019918

Type: NDA
Sponsor: MEDTECH PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NIX	PERMETHRIN	LOTION;TOPICAL	1%	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
N019918-001	NIX	PERMETHRIN	1%	LOTION / TOPICAL		RLD, RS	1990-05-02

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nix Complete Lice Treatment	PERMETHRIN	Insight Pharmaceuticals LLC	cca42777-01bf-4352-acdb-441160d69557	2025-10-23	Warnings	Exact identifier application applno (NDA): 019918 application number: NDA019918 ndc (product): 63736-035
Nix	PERMETHRIN	Insight Pharmaceuticals LLC	d6dfa64a-bb88-4438-b4e2-30c6fbb28f3e	2025-10-23	Warnings	Exact identifier application applno (NDA): 019918 application number: NDA019918 ndc (product): 63736-030
Nix Lice Killing Creme Rinse	PERMETHRIN	Geodis Logistics LLC	cf7c2429-9ae0-4435-b695-aafd5f207d27	2022-02-07	Warnings	Exact identifier application applno (NDA): 019918 application number: NDA019918 ndc (product): 63471-3006

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
63471-3006	Nix Lice Killing Creme Rinse	PERMETHRIN	Geodis Logistics LLC	NDA	Current
63471-3010	Nix FAMILY PACK Lice Killing Creme Rinse Kit	PERMETHRIN	Geodis Logistics LLC	NDA	Current
63471-3020	Nix COMPLETE Lice Treatment	PERMETHRIN	Geodis Logistics LLC	NDA	Current
63736-024	Nix	Permethrin	Insight Pharmaceuticals	NDA	Current
63736-024	Nix	Permethrin	Insight Pharmaceuticals LLC	NDA	Current
63736-024	Nix	Permethrin	Insight Pharmaceuticals LLC	NDA	Current
63736-027	Nix Complete Maximum Strength Lice Elimination	Permethrin	Insight Pharmaceuticals LLC	NDA	Current
63736-027	Nix Complete Maximum Strength Lice Elimination	Permethrin	Insight Pharmaceuticals LLC	NDA	Current
63736-030	Nix	Permethrin	Insight Pharmaceuticals LLC	NDA	Current
63736-030	Nix	Permethrin	Insight Pharmaceuticals LLC	NDA	Current
63736-035	Nix Complete Lice Treatment	Permethrin	Insight Pharmaceuticals LLC	NDA	Current
76413-358	Nix	Permethrin	Central Texas Community Health Centers	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
1812	SUPPL	2002-01-17
20423	SUPPL	1997-12-11