Treats secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in…. ANDA 218361, held by Zydus Lifesciences. Mupirocin Calcium.
As of Nov 15, 2026, ANDA 218361 (Mupirocin Calcium), held by Zydus Lifesciences, was first approved by FDA on Sep 29, 2026, with 0 approved supplements and 0 published complete response letters.
Mupirocin cream 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 |
|---|---|---|---|
| Sep 29, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mupirocin CalciumEQ 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
