Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021785
Company: HOFFMANN-LA ROCHE
Company: HOFFMANN-LA ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INVIRASE | SAQUINAVIR MESYLATE | EQ 500MG BASE | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 12/17/2004 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021785lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021785ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021785s000_InviraseTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/18/2020 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021785s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021785Orig1s025ltr.pdf | |
| 12/19/2019 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021785s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021785Orig1s024ltr.pdf | |
| 03/28/2019 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020628s047,021785s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020628Orig1s047, 021785Orig1s023ltr.pdf | |
| 03/15/2018 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020628Orig1s046,021785Orig1s022ltr.pdf | |
| 09/15/2016 | SUPPL-21 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s045,021785s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020628Orig1s045,021785Orig1s021ltr.pdf | |
| 12/16/2015 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s43-021785s19lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s043,021785Orig1s019ltr.pdf | |
| 03/27/2015 | SUPPL-18 | Labeling-Package Insert, Labeling, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s042,021785s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s042,21785Orig1s018ltr.pdf | |
| 02/26/2016 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s041,021785s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020628Orig1s041,021785Orig1s017ltr.pdf | |
| 04/21/2015 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s039,021785s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s039,021785Orig1s016ltr.pdf | |
| 02/17/2012 | SUPPL-15 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s038,021785s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020628s038,021785s015ltr.pdf | |
| 05/26/2011 | SUPPL-14 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020628s037,021785s014ltr.pdf |
| 11/30/2012 | SUPPL-11 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s034-021785s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020628Orig1s034,021785Orig1s011ltr.pdf | |
| 10/06/2010 | SUPPL-10 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s033,021785s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s033,021785s010ltr.pdf | |
| 04/27/2010 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s032,021785s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s032,021785s009ltr.pdf | |
| 01/21/2010 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s027,021785s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s027,021785s006ltr.pdf | |
| 07/11/2007 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s025,021785s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020628s025,021785s004ltr.pdf | |
| 04/03/2007 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s024,021785s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020628s024, 021785s003ltr.pdf | |
| 09/08/2005 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,s020,020628s022,s023ppi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021785_S002_FORTOVASE.pdf | |
| 09/08/2005 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,s020,020628s022,s023ppi.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/18/2020 | SUPPL-25 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021785s025lbl.pdf | |
| 09/18/2020 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021785s025lbl.pdf | |
| 12/19/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021785s024lbl.pdf | |
| 12/19/2019 | SUPPL-24 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021785s024lbl.pdf | |
| 03/28/2019 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020628s047,021785s023lbl.pdf | |
| 03/28/2019 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020628s047,021785s023lbl.pdf | |
| 03/15/2018 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf | |
| 03/15/2018 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf | |
| 09/15/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s045,021785s021lbl.pdf | |
| 09/15/2016 | SUPPL-21 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s045,021785s021lbl.pdf | |
| 02/26/2016 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s041,021785s017lbl.pdf | |
| 12/16/2015 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s43-021785s19lbl.pdf | |
| 12/16/2015 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s43-021785s19lbl.pdf | |
| 04/21/2015 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s039,021785s016lbl.pdf | |
| 04/21/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s039,021785s016lbl.pdf | |
| 03/27/2015 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s042,021785s018lbl.pdf | |
| 03/27/2015 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s042,021785s018lbl.pdf | |
| 03/27/2015 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s042,021785s018lbl.pdf | |
| 11/30/2012 | SUPPL-11 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s034-021785s011lbl.pdf | |
| 02/17/2012 | SUPPL-15 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s038,021785s015lbl.pdf | |
| 10/06/2010 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s033,021785s010lbl.pdf | |
| 04/27/2010 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s032,021785s009lbl.pdf | |
| 04/27/2010 | SUPPL-9 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s032,021785s009lbl.pdf | |
| 01/21/2010 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s027,021785s006lbl.pdf | |
| 07/11/2007 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s025,021785s004lbl.pdf | |
| 04/03/2007 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s024,021785s003lbl.pdf | |
| 09/08/2005 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf | |
| 09/08/2005 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf | |
| 12/17/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021785lbl.pdf |