MUPIROCIN CALCIUM | A201587 | GLENMARK PHARMACEUTICALS INC USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Encube Ethicals Private Limited FDA-2018-P-1516 · 3 docket documents Encube Ethicals Private Limited filed this citizen petition on April 13, 2018, requesting that the FDA designate ANDA 201587 held by Glenmark Pharmaceuticals Inc USA as a reference standard for Mupirocin Calcium Cream, EQ 2% Base, because the currently designated reference listed drug and reference | 505(q) | 2018-04-16 | Open | Encube Ethicals Private Limited |
Citizen Petition from Prinston Pharmaceutical Inc. FDA-2018-P-0829 · 3 docket documents Prinston Pharmaceutical Inc. filed this citizen petition pursuant to 21 C.F.R. §§ 10.25(a) and 10.30 requesting that the FDA designate ANDA 201587 held by Glenmark Pharmaceuticals Inc USA as a Reference Standard for Mupirocin Calcium Cream, EQ 2% Base, to replace the current reference standard NDA 0 | 505(q) | 2018-02-22 | Granted | Prinston Pharmaceutical Inc. |
Citizen Petition from Goodwin Procter LLP FDA-2017-P-6108 · 3 docket documents Goodwin Procter LLP filed this citizen petition requesting that FDA amend the Orange Book to designate ANDA 201587 as a Reference Standard for mupirocin calcium cream, 2% Base. The petition argues that the current reference listed drug, Bactroban (NDA 050746), has been unavailable since a July 2016 | 505(q) | 2017-10-12 | Granted | Goodwin Procter LLP |
Citizen Petition from Glasshouse Pharmaceuticals Limited Canada FDA-2017-P-3484 · 4 docket documents Glasshouse Pharmaceuticals Limited Canada filed this petition on June 2, 2017, requesting that the FDA designate Mupirocin Calcium Cream 2% manufactured by Glenmark Generics Inc. U.S.A. and approved under ANDA A201587 as the Reference Standard for mupirocin calcium cream 2%, replacing Bactroban Crea | Other | 2017-06-06 | Granted | Glasshouse Pharmaceuticals Limited Canada |
Citizen Petition from GlaxoSmithKline FDA-2004-P-0537 · 10 docket documents GlaxoSmithKline filed this citizen petition under 21 CFR 10.30 requesting that the FDA Commissioner refrain from receiving, reviewing, and approving any Abbreviated New Drug Applications (ANDAs) for nasal mupirocin calcium products containing the amorphous form of the active pharmaceutical ingredien | 505(q) | 2008-05-28 | Withdrawn | GlaxoSmithKline |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.02
per gm
Lowest NADAC/Unit
$0.7643
per gm
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 68462056417MUPIROCIN 2% CREAM | $1.02 | GM | Generic | — | 2026-06-17 |
| 68462056435MUPIROCIN 2% CREAM | $0.7643 | GM | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.