Drugs@FDA: FDA-Approved Drugs
Company: ALVOGEN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SPECTAZOLE | ECONAZOLE NITRATE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/23/1982 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
01/21/2020 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018751s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018751Orig1s025ltr.pdf | |
09/07/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018751s024lbl.pdf | |
03/28/2014 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018751s023lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018751Orig1s023ltr.pdf | |
07/11/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/04/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/20/2001 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/23/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/17/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/24/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
09/10/1992 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/09/1990 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/25/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
12/18/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/28/1985 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
01/08/1985 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/22/1985 | 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 |
---|---|---|---|---|---|
01/21/2020 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018751s025lbl.pdf | |
09/07/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018751s024lbl.pdf | |
03/28/2014 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018751s023lbledt.pdf |