FDA Orange Book · active-ingredient family
Dicloxacillin sodium
Dicloxacillin sodium 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:PATHOCIL · NDA 050011
3
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PATHOCILRLD×2 | WYETH AYERST | NDA 050011 | — | Approved Prior to Jan 1, 1982 | |
| DYNAPEN | APOTHECON | NDA 050337 | — | Approved Prior to Jan 1, 1982 | |
| PATHOCIL | WYETH AYERST | NDA 050092 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DICLOXACILLIN SODIUM×2 | AUROBINDO PHARMA | ANDA 216845 | AB | Sep 23, 2022 | |
| DICLOXACILLIN SODIUM×2 | TEVA | ANDA 062286 | AB | Jun 03, 1982 | |
| DICLOXACILLIN SODIUM×3 | CHARTWELL RX | ANDA 061454 | — | Approved Prior to Jan 1, 1982 | |
| DYCILL×2 | GLAXOSMITHKLINE | ANDA 060254 | — | Approved Prior to Jan 1, 1982 | |
| DYCILL×2 | GLAXOSMITHKLINE | ANDA 062238 | — | Approved Prior to Jan 1, 1982 | |
| DICLOXACILLIN SODIUM | APOTHECON | ANDA 061455 | — | 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.
Dicloxacillin sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
