Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076005
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ECONAZOLE NITRATE | ECONAZOLE NITRATE | 1% | 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 |
---|---|---|---|---|---|---|---|
11/26/2002 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76005_Econazole Nirate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76005_Econazole Nirate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076005_econazole-nirate_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/08/2020 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
07/15/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/26/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76005_Econazole Nirate_Prntlbl.pdf |
ECONAZOLE NITRATE
CREAM;TOPICAL; 1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ECONAZOLE NITRATE | ECONAZOLE NITRATE | 1% | CREAM;TOPICAL | Prescription | No | AB | 076479 | PADAGIS ISRAEL |
ECONAZOLE NITRATE | ECONAZOLE NITRATE | 1% | CREAM;TOPICAL | Prescription | No | AB | 076005 | TARO |