Orange Book product · Brand (NDA)
BACTROBAN
MUPIROCIN
At a glance
Dec 31, 1987
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 31, 1987
39 yr ago
Today
Pharmaceutical detail
Active ingredient
MUPIROCIN
Strength
2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
OINTMENT
Route
TOPICAL
TE code
Not listed
Application
NDA 050591
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2002CENTANYBrand (NDA)
NDA 050788 · PADAGIS US
- 2025MUPIROCINGeneric (ANDA)
ANDA 217943 · ENCUBE
- 2011MUPIROCINGeneric (ANDA)
ANDA 090480 · GLENMARK PHARMS
- 2005MUPIROCINGeneric (ANDA)
ANDA 065192 · FOUGERA PHARMS
- 2005MUPIROCINGeneric (ANDA)
ANDA 065170 · SUN PHARMA CANADA
- 2003MUPIROCINGeneric (ANDA)
ANDA 065123 · PADAGIS ISRAEL
- 2003MUPIROCINGeneric (ANDA)
ANDA 065085 · TEVA
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.
