Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050742
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STROMECTOL IVERMECTIN 6MG TABLET;ORAL Discontinued None No No
STROMECTOL IVERMECTIN 3MG TABLET;ORAL Prescription AB 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
11/22/1996 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050742ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/11/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/07/2015 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/15/2009 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050742s026ltr.pdf
06/11/2009 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050742s024,s025ltr.pdf
06/11/2009 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050742s024,s025ltr.pdf
05/01/2009 SUPPL-23 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s023lbl.pdf
09/12/2008 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050742s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050742s022ltr.pdf
09/26/2007 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050742s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050742s019, 050742s021ltr.pdf
02/26/2008 SUPPL-20 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050742s020ltr.pdf
09/26/2007 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050742s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050742s019, 050742s021ltr.pdf
01/20/2006 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050742s017,s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050742s017ltr.pdf
01/20/2006 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050742s017,s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050742s017ltr.pdf
11/18/2004 SUPPL-15 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50742s015lbl.pdf
02/12/2004 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50742slr012,013_stomectol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50742slr012,013ltr.pdf
02/12/2004 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50742slr012,013_stomectol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50742slr012,013ltr.pdf
01/15/2003 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50742slr011_stromectol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50742slr011ltr.pdf
12/12/2002 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/28/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/2001 SUPPL-5 Labeling

Label is not available on this site.

11/10/1999 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/2001 SUPPL-2 Labeling

Label is not available on this site.

10/08/1998 SUPPL-1 Manufacturing (CMC)-Formulation Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50-742s001_Stromectol.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/15/2009 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s026lbl.pdf
06/11/2009 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s024s025lbl.pdf
06/11/2009 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s024s025lbl.pdf
05/01/2009 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s023lbl.pdf
09/12/2008 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050742s022lbl.pdf
09/26/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050742s019s021lbl.pdf
09/26/2007 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050742s019s021lbl.pdf
01/20/2006 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050742s017,s018lbl.pdf
01/20/2006 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050742s017,s018lbl.pdf
11/18/2004 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50742s015lbl.pdf
02/12/2004 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50742slr012,013_stomectol_lbl.pdf
02/12/2004 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50742slr012,013_stomectol_lbl.pdf
01/15/2003 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50742slr011_stromectol_lbl.pdf

STROMECTOL

TABLET;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IVERMECTIN IVERMECTIN 3MG TABLET;ORAL Prescription No AB 204154 EDENBRIDGE PHARMS
STROMECTOL IVERMECTIN 3MG TABLET;ORAL Prescription Yes AB 050742 MERCK SHARP DOHME

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