Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218361
Company: ZYDUS LIFESCIENCES
Company: ZYDUS LIFESCIENCES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MUPIROCIN CALCIUM | MUPIROCIN CALCIUM | EQ 2% BASE | CREAM;TOPICAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/29/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
MUPIROCIN CALCIUM
CREAM;TOPICAL; EQ 2% BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MUPIROCIN | MUPIROCIN CALCIUM | EQ 2% BASE | CREAM;TOPICAL | Prescription | No | AB | 213053 | ALEMBIC |
| MUPIROCIN | MUPIROCIN CALCIUM | EQ 2% BASE | CREAM;TOPICAL | Prescription | No | AB | 214811 | AMNEAL |
| MUPIROCIN | MUPIROCIN CALCIUM | EQ 2% BASE | CREAM;TOPICAL | Prescription | No | AB | 213076 | ENCUBE |
| MUPIROCIN | MUPIROCIN CALCIUM | EQ 2% BASE | CREAM;TOPICAL | Prescription | No | AB | 201587 | GLENMARK PHARMS |
| MUPIROCIN | MUPIROCIN CALCIUM | EQ 2% BASE | CREAM;TOPICAL | Prescription | No | AB | 207116 | SUN PHARMA CANADA |
| MUPIROCIN CALCIUM | MUPIROCIN CALCIUM | EQ 2% BASE | CREAM;TOPICAL | Prescription | No | AB | 218361 | ZYDUS LIFESCIENCES |