Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065123
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MUPIROCIN | MUPIROCIN | 2% | OINTMENT;TOPICAL | Prescription | AB | No | Yes |
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/2003/065123.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/03/2023 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
12/06/2016 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
12/06/2016 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
12/06/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
04/14/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
07/18/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
11/28/2005 | SUPPL-2 | 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 |