Orange Book product · Brand (NDA)
BACTROBAN
MUPIROCIN CALCIUM
At a glance
Dec 11, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 11, 1997
28 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
MUPIROCIN CALCIUM
Strength
EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 050746
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.
- 1995BACTROBANBrand (NDA)
NDA 050703 · GLAXOSMITHKLINE
- 2022MUPIROCINGeneric (ANDA)
ANDA 214811 · AMNEAL
- 2022MUPIROCINGeneric (ANDA)
ANDA 212465 · PADAGIS ISRAEL
- 2021MUPIROCINGeneric (ANDA)
ANDA 213053 · ALEMBIC
- 2021MUPIROCINGeneric (ANDA)
ANDA 213076 · ENCUBE
- 2020MUPIROCINGeneric (ANDA)
ANDA 207116 · SUN PHARMA CANADA
- 2013MUPIROCINGeneric (ANDA)
ANDA 201587 · GLENMARK PHARMS
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.
