Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020628
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 200MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 12/06/1995 | 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/pre96/020628Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/28/2019 | SUPPL-47 | Labeling-Medication Guide, Labeling-Package Insert |
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-46 | 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-45 | Labeling-Package Insert |
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 | |
| 02/01/2016 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/2015 | SUPPL-43 | Labeling-Medication Guide, Labeling-Package Insert |
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-42 | 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-41 | 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-39 | Labeling-Package Insert, Labeling-Medication Guide |
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-38 | 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-37 | 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-34 | 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-33 | 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-32 | Labeling-Patient Package Insert, Labeling-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-27 | 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-25 | 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-24 | 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-23 | 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/2005/020628_S023_FORTOVASE.pdf | |
| 09/08/2005 | SUPPL-22 | 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 | |
| 12/24/2003 | SUPPL-20 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20628se2-020_Invirase_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20628se2-020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20628s020ppi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020628_S020_INVIRASE.pdf | |
| 07/02/2002 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20628s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20628s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-628s016_Invirase.cfm | |
| 05/11/2000 | SUPPL-15 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020628_S015_Invirase.pdf |
| 11/14/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 09/08/1999 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1999 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/24/1997 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1997 | SUPPL-7 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20628ap_s007.pdf |
| 07/31/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1996 | SUPPL-4 | Efficacy-Accelerated Approval |
Label is not available on this site. |
||
| 10/03/1996 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/26/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/28/2019 | SUPPL-47 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020628s047,021785s023lbl.pdf | |
| 03/28/2019 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020628s047,021785s023lbl.pdf | |
| 03/15/2018 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf | |
| 03/15/2018 | SUPPL-46 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf | |
| 09/15/2016 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s045,021785s021lbl.pdf | |
| 02/26/2016 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s041,021785s017lbl.pdf | |
| 12/16/2015 | SUPPL-43 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s43-021785s19lbl.pdf | |
| 12/16/2015 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s43-021785s19lbl.pdf | |
| 04/21/2015 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s039,021785s016lbl.pdf | |
| 04/21/2015 | SUPPL-39 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s039,021785s016lbl.pdf | |
| 03/27/2015 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s042,021785s018lbl.pdf | |
| 11/30/2012 | SUPPL-34 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s034-021785s011lbl.pdf | |
| 02/17/2012 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s038,021785s015lbl.pdf | |
| 10/06/2010 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s033,021785s010lbl.pdf | |
| 04/27/2010 | SUPPL-32 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s032,021785s009lbl.pdf | |
| 04/27/2010 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s032,021785s009lbl.pdf | |
| 01/21/2010 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s027,021785s006lbl.pdf | |
| 07/11/2007 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s025,021785s004lbl.pdf | |
| 04/03/2007 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s024,021785s003lbl.pdf | |
| 09/08/2005 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf | |
| 09/08/2005 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf | |
| 12/24/2003 | SUPPL-20 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20628se2-020_Invirase_lbl.pdf | |
| 07/02/2002 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20628s16lbl.pdf |