FDA Orange Book · active-ingredient family
Oxacillin sodium
Oxacillin sodium is approved as 4 brand and 27 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BACTOCILL IN PLASTIC CONTAINER · NDA 050640
4
Brand (NDA)
27
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for solution, injectable, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BACTOCILL IN PLASTIC CONTAINERRLD×2 | BAXTER HLTHCARE | NDA 050640 | — | Oct 26, 1989 | |
| OXACILLIN SODIUMRLD×5 | APOTHECON | NDA 050195 | — | Approved Prior to Jan 1, 1982 | |
| PROSTAPHLIN | APOTHECON | NDA 050118 | — | Approved Prior to Jan 1, 1982 | |
| PROSTAPHLIN | APOTHECON | NDA 050194 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (27)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXACILLIN SODIUM | FRESENIUS KABI USA | ANDA 206199 | AP | Jul 27, 2020 | |
| OXACILLIN SODIUM×2 | FRESENIUS KABI USA | ANDA 206198 | AP | Jul 20, 2020 | |
| OXACILLIN SODIUM | WOCKHARDT BIO AG | ANDA 207148 | AP | Nov 24, 2017 | |
| OXACILLIN SODIUM | PIRAMAL CRITICAL | ANDA 206760 | — | Oct 26, 2017 | |
| OXACILLIN SODIUM×2 | PIRAMAL CRITICAL | ANDA 206681 | — | Sep 11, 2017 | |
| OXACILLIN SODIUM×2 | WOCKHARDT BIO AG | ANDA 207147 | AP | Jul 31, 2017 | |
| OXACILLIN SODIUM×2 | HOSPIRA | ANDA 203950 | — | Dec 11, 2015 | |
| OXACILLIN SODIUM×2 | ONESOURCE SPECIALTY | ANDA 091486 | — | Aug 25, 2014 | |
| OXACILLIN SODIUM×2 | EUGIA PHARMA SPECLTS | ANDA 201539 | AP | Jan 18, 2013 | |
| OXACILLIN SODIUM | EUGIA PHARMA SPECLTS | ANDA 201538 | AP | Jan 18, 2013 | |
| OXACILLIN SODIUM×2 | SAGENT PHARMS | ANDA 091246 | — | Mar 30, 2012 | |
| OXACILLIN SODIUM | SAGENT PHARMS | ANDA 091245 | AP | Mar 30, 2012 | |
| OXACILLIN SODIUM×5 | ISTITUTO BIO ITA SPA | ANDA 062798 | — | Dec 11, 1995 | |
| OXACILLIN SODIUM×6 | ELKINS SINN | ANDA 062711 | — | Feb 03, 1989 | |
| OXACILLIN SODIUM×5 | WATSON LABS INC | ANDA 062856 | — | Oct 26, 1988 | |
| OXACILLIN SODIUM | WATSON LABS INC | ANDA 062984 | — | Sep 29, 1988 | |
| OXACILLIN SODIUM×2 | SANDOZ | ANDA 062737 | — | Dec 23, 1986 | |
| BACTOCILL×2 | GLAXOSMITHKLINE | ANDA 062736 | — | Dec 19, 1986 | |
| BACTOCILL×5 | GLAXOSMITHKLINE | ANDA 061334 | — | Mar 26, 1982 | |
| BACTOCILL×2 | GLAXOSMITHKLINE | ANDA 061336 | — | Approved Prior to Jan 1, 1982 | |
| BACTOCILL×2 | GLAXOSMITHKLINE | ANDA 062241 | — | Approved Prior to Jan 1, 1982 | |
| OXACILLIN SODIUM×2 | ANI PHARMS | ANDA 062222 | — | Approved Prior to Jan 1, 1982 | |
| OXACILLIN SODIUM×2 | APOTHECON | ANDA 061450 | — | Approved Prior to Jan 1, 1982 | |
| BACTOCILL | GLAXOSMITHKLINE | ANDA 062321 | — | Approved Prior to Jan 1, 1982 | |
| OXACILLIN SODIUM | APOTHECON | ANDA 061457 | — | Approved Prior to Jan 1, 1982 | |
| OXACILLIN SODIUM | TEVA | ANDA 062252 | — | Approved Prior to Jan 1, 1982 | |
| OXACILLIN SODIUM×5 | SANDOZ | ANDA 061490 | — | 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.
Oxacillin sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
