Treats secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in…. ANDA 214811, held by Amneal. Mupirocin Calcium.
As of Nov 15, 2026, ANDA 214811 (Mupirocin), held by Amneal, was first approved by FDA on Nov 15, 2022, 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 |
|---|---|---|---|
| Nov 15, 2022 | 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
