FDA Orange Book · active-ingredient family
Permethrin
Permethrin is approved as 3 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NIX · NDA 019918
3
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, lotion
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NIXRLD | MEDTECH PRODUCTS | NDA 019918 | — | May 02, 1990 | |
| ELIMITERLD | AUROBINDO PHARMA USA | NDA 019855 | AB | Aug 25, 1989 | |
| NIX | GLAXOSMITHKLINE | NDA 019435 | — | Mar 31, 1986 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PERMETHRIN | DR REDDYS LABS EU | ANDA 209732 | — | Aug 01, 2023 | |
| PERMETHRIN | ENCUBE ETHICALS | ANDA 211303 | AB | Apr 03, 2019 | |
| PERMETHRIN | PADAGIS ISRAEL | ANDA 076369 | AB | Apr 21, 2003 | |
| PERMETHRIN | PERRIGO NEW YORK | ANDA 076090 | — | Dec 20, 2001 | |
| PERMETHRIN | ACTAVIS MID ATLANTIC | ANDA 075014 | — | Mar 28, 2000 | |
| PERMETHRIN | ACTAVIS LABS | ANDA 074806 | AB | Jan 23, 1998 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Permethrin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
