Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065085
Company: TEVA
Company: TEVA
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 |
---|---|---|---|---|---|---|---|
11/07/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/065085.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/16/2021 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
07/16/2021 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
12/28/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
12/28/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
02/26/2004 | SUPPL-1 | Labeling |
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 |