Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020666
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBENZA ALBENDAZOLE 200MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/11/1996 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/11/2015 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020666Orig1s009ltr.pdf
10/20/2009 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020666s005,s006ltr.pdf
10/20/2009 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020666s005,s006ltr.pdf
08/20/2007 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020666s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020666s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/11/2015 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf
10/20/2009 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf
10/20/2009 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf
08/20/2007 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020666s004lbl.pdf

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