Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LANTUS | INSULIN GLARGINE RECOMBINANT | 100 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | No | Yes |
LANTUS SOLOSTAR | INSULIN GLARGINE RECOMBINANT | 300 UNITS/3ML (100 UNITS/ML) | INJECTABLE;INJECTION | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
04/20/2000 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21081ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21081_Lantus.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/15/2019 | SUPPL-74 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf | |
11/15/2019 | SUPPL-73 | Supplement |
Label is not available on this site. |
||
05/09/2019 | SUPPL-72 | Supplement |
Label is not available on this site. |
||
11/29/2018 | SUPPL-71 | Supplement |
Label is not available on this site. |
||
04/13/2016 | SUPPL-65 | Supplement |
Label is not available on this site. |
||
06/16/2015 | SUPPL-64 | Supplement |
Label is not available on this site. |
||
07/17/2015 | SUPPL-63 | Supplement |
Label is not available on this site. |
||
02/25/2015 | SUPPL-62 | Supplement |
Label is not available on this site. |
||
09/05/2014 | SUPPL-61 | Supplement |
Label is not available on this site. |
||
06/05/2013 | SUPPL-59 | Supplement |
Label is not available on this site. |
||
07/18/2013 | SUPPL-58 | Supplement |
Label is not available on this site. |
||
10/18/2013 | SUPPL-57 | Supplement |
Label is not available on this site. |
||
03/27/2013 | SUPPL-56 | Supplement |
Label is not available on this site. |
||
05/16/2013 | SUPPL-55 | Supplement |
Label is not available on this site. |
||
08/14/2013 | SUPPL-49 | Supplement |
Label is not available on this site. |
||
09/09/2009 | SUPPL-34 | Supplement |
Label is not available on this site. |
||
04/25/2007 | SUPPL-24 | Supplement |
Label is not available on this site. |
||
03/15/2005 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
02/11/2005 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
08/10/2004 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
05/01/2003 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
08/15/2002 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
01/31/2001 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
03/07/2001 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
11/17/2000 | SUPPL-1 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/15/2019 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.pdf | |
11/15/2019 | SUPPL-74 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.pdf | |
04/20/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21081lbl.pdf |
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