FDA Orange Book · active-ingredient family
Nafcillin sodium
Nafcillin sodium is approved as 5 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NALLPEN IN PLASTIC CONTAINER · NDA 050655
5
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for solution, injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NALLPEN IN PLASTIC CONTAINERRLD×2 | BAXTER HLTHCARE | NDA 050655 | — | Oct 31, 1989 | |
| UNIPENRLD×6 | WYETH AYERST | NDA 050320 | — | Approved Prior to Jan 1, 1982 | |
| UNIPEN | WYETH AYERST | NDA 050111 | — | Approved Prior to Jan 1, 1982 | |
| UNIPEN | WYETH AYERST | NDA 050199 | — | Approved Prior to Jan 1, 1982 | |
| UNIPEN | WYETH AYERST | NDA 050462 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NAFCILLIN SODIUM | FRESENIUS | ANDA 206761 | — | Jun 02, 2020 | |
| NAFCILLIN SODIUM×2 | FRESENIUS | ANDA 206682 | — | Dec 10, 2019 | |
| NAFCILLIN SODIUM×2 | ONESOURCE SPECIALTY | ANDA 200002 | AP | Apr 07, 2014 | |
| NAFCILLIN SODIUM×2 | EUGIA PHARMA SPECLTS | ANDA 091613 | AP | Dec 26, 2012 | |
| NAFCILLIN SODIUM | EUGIA PHARMA SPECLTS | ANDA 091614 | AP | Dec 26, 2012 | |
| NAFCILLIN SODIUM×2 | SAGENT PHARMS | ANDA 090582 | AP | Aug 24, 2012 | |
| NAFCILLIN SODIUM | SAGENT PHARMS | ANDA 090580 | AP | Aug 24, 2012 | |
| NAFCILLIN SODIUM×2 | ANTIBIOTICE | ANDA 090560 | AP | Oct 03, 2011 | |
| NAFCILLIN SODIUM×2 | ISTITUTO BIO ITA SPA | ANDA 090002 | AP | Jun 30, 2011 | |
| NAFCILLIN SODIUM | ISTITUTO BIO ITA SPA | ANDA 090005 | AP | Apr 20, 2011 | |
| NAFCILLIN SODIUM×5 | WATSON LABS INC | ANDA 062844 | — | Oct 26, 1988 | |
| NAFCILLIN SODIUM | WATSON LABS INC | ANDA 063008 | — | Sep 29, 1988 | |
| NAFCILLIN SODIUM×2 | SANDOZ | ANDA 062732 | — | Dec 23, 1986 | |
| NALLPEN×2 | GLAXOSMITHKLINE | ANDA 062755 | — | Dec 19, 1986 | |
| UNIPEN×3 | WYETH AYERST | ANDA 062717 | — | Dec 16, 1986 | |
| NAFCILLIN SODIUM×4 | SANDOZ | ANDA 062527 | — | Aug 02, 1984 | |
| NAFCILLIN SODIUM×4 | APOTHECON | ANDA 061984 | — | Approved Prior to Jan 1, 1982 | |
| NALLPEN×4 | GLAXOSMITHKLINE | ANDA 061999 | — | 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.
Nafcillin sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
