Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018613
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OVIDE | MALATHION | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/02/1982 | 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 |
|---|---|---|---|---|---|
| 12/09/2011 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018613s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018613s017ltr.pdf | |
| 04/04/2003 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018613s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18613slr011ltr.pdf | |
| 04/30/1999 | SUPPL-10 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18613s009s010_ovide.pdf |
| 04/30/1999 | SUPPL-9 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18613s009s010_ovide.pdf |
| 07/14/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/13/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1988 | 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 |
|---|---|---|---|---|---|
| 12/09/2011 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018613s017lbl.pdf | |
| 04/04/2003 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018613s011lbl.pdf |