Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018613
Company: TARO PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OVIDE MALATHION 0.5% 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

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