Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050742
Company: MERCK SHARP DOHME
Company: MERCK SHARP DOHME
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STROMECTOL | IVERMECTIN | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 03/14/2022 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050742s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050742Orig1s030ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 03/14/2022 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050742s030lbl.pdf | |
| 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 |