Treats secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in…. ANDA 213076, held by Encube. Mupirocin Calcium.
As of Nov 15, 2026, ANDA 213076 (Mupirocin), held by Encube, was first approved by FDA on Aug 31, 2021, with 0 approved supplements and 0 published complete response letters.
Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| MupirocinEQ 2% BASE · cream;topical | Mupirocin Calcium | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
