Treats secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in…. ANDA 201587, held by Glenmark Pharms. Mupirocin Calcium.
As of Nov 15, 2026, ANDA 201587 (Mupirocin), held by Glenmark Pharms, was first approved by FDA on Jan 24, 2013, with 7 approved supplements and 0 published complete response letters.
PIRNUO 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 |
|---|---|---|---|
| Jan 24, 2013 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| MupirocinEQ 2% BASE · cream;topical | Mupirocin Calcium | Rx |
| Jul 8, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jul 8, 2024 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jul 16, 2019 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 30, 2018 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 30, 2018 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 30, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 30, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 24, 2013 | Original application | Approved |
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
