FDA Orange Book · active-ingredient family
Mupirocin
Mupirocin 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 050591
2
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · ointment
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BACTROBANRLD | GLAXOSMITHKLINE | NDA 050591 | — | Dec 31, 1987 | |
| CENTANY | PADAGIS US | NDA 050788 | — | Dec 04, 2002 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MUPIROCIN | ENCUBE | ANDA 217943 | AB | May 13, 2025 | |
| MUPIROCIN | GLENMARK PHARMS | ANDA 090480 | AB | Jun 08, 2011 | |
| MUPIROCIN | FOUGERA PHARMS | ANDA 065192 | AB | Nov 30, 2005 | |
| MUPIROCIN | SUN PHARMA CANADA | ANDA 065170 | AB | Sep 23, 2005 | |
| MUPIROCIN | PADAGIS ISRAEL | ANDA 065123 | AB | Nov 07, 2003 | |
| MUPIROCIN | TEVA | ANDA 065085 | AB | Nov 07, 2003 |
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
