FDA Orange Book · active-ingredient family
Lindane
Lindane is approved as 2 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KWELL · NDA 006309
2
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, lotion, shampoo
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LINDANE | WOCKHARDT BIO AG | ANDA 088191 | — | Sep 18, 1984 | |
| LINDANE | WOCKHARDT BIO AG | ANDA 088190 | — | Aug 16, 1984 | |
| SCABENE | STIEFEL | ANDA 087940 | — | Apr 08, 1983 | |
| KWELL×2 | REED AND CARNRICK | ANDA 084218 | — | Approved Prior to Jan 1, 1982 | |
| GAMENE | SOLA BARNES HIND | ANDA 084989 | — | Approved Prior to Jan 1, 1982 | |
| LINDANE | OLTA PHARMS | ANDA 087313 | — | Approved Prior to Jan 1, 1982 | |
| SCABENE | STIEFEL | ANDA 086769 | — | Approved Prior to Jan 1, 1982 | |
| GAMENE | SOLA BARNES HIND | ANDA 084988 | — | Approved Prior to Jan 1, 1982 | |
| KWELL | REED AND CARNRICK | ANDA 084219 | — | Approved Prior to Jan 1, 1982 | |
| LINDANE | OLTA PHARMS | ANDA 087266 | — | Approved Prior to Jan 1, 1982 |
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.
Lindane — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
