FDA Orange Book · active-ingredient family
Mupirocin calcium
Mupirocin calcium is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BACTROBAN · NDA 050746
2
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, ointment
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BACTROBANRLD | GLAXOSMITHKLINE | NDA 050746 | — | Dec 11, 1997 | |
| BACTROBANRLD | GLAXOSMITHKLINE | NDA 050703 | — | Sep 18, 1995 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MUPIROCIN | AMNEAL | ANDA 214811 | AB | Nov 15, 2022 | |
| MUPIROCIN | PADAGIS ISRAEL | ANDA 212465 | — | Aug 03, 2022 | |
| MUPIROCIN | ALEMBIC | ANDA 213053 | BX | Nov 16, 2021 | |
| MUPIROCIN | ENCUBE | ANDA 213076 | AB | Aug 31, 2021 | |
| MUPIROCIN | SUN PHARMA CANADA | ANDA 207116 | AB | Apr 27, 2020 | |
| MUPIROCIN | GLENMARK PHARMS | ANDA 201587 | AB | Jan 24, 2013 |
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.
Mupirocin calcium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
