Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019824
Company: MEDIMETRIKS PHARMS
Company: MEDIMETRIKS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOPROX | CICLOPIROX | 0.77% | SUSPENSION;TOPICAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
12/30/1988 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/04/2016 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
06/28/2013 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018748Orig1s024,019824Orig1s023,020519Orig1s016ltr.pdf | |
03/26/2003 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr009_loprox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19824slr009ltr.pdf | |
03/26/2003 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr008_loprox_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19824slr008ltr.pdf | |
06/09/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/17/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/23/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
09/11/1990 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/08/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/28/2013 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf | |
03/26/2003 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr009_loprox_lbl.pdf | |
03/26/2003 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr008_loprox_lbl.pdf |
LOPROX
SUSPENSION;TOPICAL; 0.77%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CICLOPIROX | CICLOPIROX | 0.77% | SUSPENSION;TOPICAL | Prescription | No | AB | 076422 | FOUGERA PHARMS |
CICLOPIROX | CICLOPIROX | 0.77% | SUSPENSION;TOPICAL | Prescription | No | AB | 077676 | PADAGIS ISRAEL |
CICLOPIROX | CICLOPIROX | 0.77% | SUSPENSION;TOPICAL | Prescription | No | AB | 077092 | TARO |
LOPROX | CICLOPIROX | 0.77% | SUSPENSION;TOPICAL | Prescription | Yes | AB | 019824 | MEDIMETRIKS PHARMS |