Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090480
Company: GLENMARK PHARMS
Company: GLENMARK PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MUPIROCIN | MUPIROCIN | 2% | OINTMENT;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 |
---|---|---|---|---|---|---|---|
06/08/2011 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/04/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
08/04/2021 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
01/05/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
01/05/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
MUPIROCIN
OINTMENT;TOPICAL; 2%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MUPIROCIN | MUPIROCIN | 2% | OINTMENT;TOPICAL | Prescription | No | AB | 065192 | FOUGERA PHARMS |
MUPIROCIN | MUPIROCIN | 2% | OINTMENT;TOPICAL | Prescription | No | AB | 090480 | GLENMARK PHARMS |
MUPIROCIN | MUPIROCIN | 2% | OINTMENT;TOPICAL | Prescription | No | AB | 065123 | PADAGIS ISRAEL |
MUPIROCIN | MUPIROCIN | 2% | OINTMENT;TOPICAL | Prescription | No | AB | 065170 | TARO |
MUPIROCIN | MUPIROCIN | 2% | OINTMENT;TOPICAL | Prescription | No | AB | 065085 | TEVA |