Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021462
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALIMTA | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | AP | Yes | Yes |
| ALIMTA | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | AP | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/31/2022 | SUPPL-55 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021462s055lbl.pdf | |
| 01/30/2019 | SUPPL-53 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021462s053lbl.pdf | |
| 06/04/2018 | SUPPL-51 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462s051lbl.pdf | |
| 04/17/2018 | SUPPL-52 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462Orig1s052lbl.pdf | |
| 10/11/2017 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021462s050lbl.pdf | |
| 10/11/2017 | SUPPL-50 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021462s050lbl.pdf | |
| 09/12/2013 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s045lbl.pdf | |
| 01/18/2013 | SUPPL-42 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s042lbl.pdf |
| 11/09/2012 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s043lbl.pdf | |
| 10/17/2012 | SUPPL-39 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s039lbl.pdf | |
| 06/04/2012 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s040lbl.pdf | |
| 11/18/2011 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf | |
| 11/18/2011 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf | |
| 11/18/2011 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf | |
| 03/17/2011 | SUPPL-33 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s033lbl.pdf | |
| 07/02/2009 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf | |
| 07/02/2009 | SUPPL-21 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s021lbl.pdf | |
| 07/02/2009 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf | |
| 09/26/2008 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021462s015lbl.pdf | |
| 09/07/2007 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s012lbl.pdf | |
| 09/07/2007 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s012lbl.pdf | |
| 02/02/2007 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s006lbl.pdf | |
| 02/02/2007 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s006lbl.pdf | |
| 07/28/2006 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021462s004lbl.pdf | |
| 08/19/2004 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021677lbl.pdf | |
| 02/04/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021462lbl.pdf |