Treats secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in…. ANDA 207116, held by Sun Pharma Canada. Mupirocin Calcium.
As of Nov 15, 2026, ANDA 207116 (Mupirocin), held by Sun Pharma Canada, was first approved by FDA on Apr 27, 2020, 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 |
|---|---|---|---|
| Apr 27, 2020 | 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
