Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076075
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ECONAZOLE NITRATE | ECONAZOLE NITRATE | 1% | CREAM;TOPICAL | Discontinued | None | 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/anda/2002/76075_Econazole%20Nitrate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/76075_Econazole%20Nitrate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075075_econazole.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/29/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
05/16/2005 | SUPPL-5 | Labeling |
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/anda/2002/76075_Econazole%20Nitrate_Prntlbl.pdf |