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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/04/2004 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021462lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21462ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021462ppilbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-462_Alimta.cfm |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021462s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021462Orig1s055ltr.pdf | |
| 01/30/2019 | SUPPL-53 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021462s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021462Orig1s053ltr.pdf | |
| 04/17/2018 | SUPPL-52 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462Orig1s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021462Orig1s052ltr.pdf | |
| 06/04/2018 | SUPPL-51 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021462s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021462Orig1s051ltr.pdf | |
| 10/11/2017 | SUPPL-50 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021462s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021462Orig1s050ltr.pdf | |
| 01/08/2016 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/2014 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2013 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021462Orig1s045ltr.pdf | |
| 11/09/2012 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462Orig1s043ltr.pdf | |
| 01/18/2013 | SUPPL-42 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021462s042lbl.pdf | |
| 03/13/2013 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/2012 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462s040ltr.pdf | |
| 10/17/2012 | SUPPL-39 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021462s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021462Orig1s039ltr.pdf | |
| 03/17/2011 | SUPPL-33 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s033ltr.pdf | |
| 11/18/2011 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf | |
| 11/18/2011 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf | |
| 11/18/2011 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s029s030s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021462s029,s030,s032ltr.pdf | |
| 07/02/2009 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf | |
| 07/02/2009 | SUPPL-21 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf | |
| 07/02/2009 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf | |
| 09/26/2008 | SUPPL-15 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021462s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021462s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021462s015.pdf | |
| 09/07/2007 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021462s012ltr.pdf | |
| 02/02/2007 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021462s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021462s006ltr.pdf | |
| 07/28/2006 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021462s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021462s004LTR.pdf | |
| 08/19/2004 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021677lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21677,21462s001ltr.pdf |
| 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 |
ALIMTA
POWDER;INTRAVENOUS; EQ 500MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALIMTA | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 021462 | LILLY |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 203485 | ACCORD HLTHCARE |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 203774 | APOTEX |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 214436 | BAXTER HLTHCARE CORP |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 202596 | DR REDDYS |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 214632 | EUGIA PHARMA |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 090384 | FRESENIUS KABI USA |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 208696 | JIANGSU HANSOH PHARM |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 215479 | MEITHEAL |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 207352 | NANG KUANG PHARM CO |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 204890 | QILU PHARM HAINAN |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211899 | WAVERLEY PHARMA INC |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 500MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 214073 | ZYDUS PHARMS |
POWDER;INTRAVENOUS; EQ 100MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALIMTA | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 021462 | LILLY |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 203485 | ACCORD HLTHCARE |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 203774 | APOTEX |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 214436 | BAXTER HLTHCARE CORP |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 202596 | DR REDDYS |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 214632 | EUGIA PHARMA |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 090384 | FRESENIUS KABI USA |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 208696 | JIANGSU HANSOH PHARM |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 215479 | MEITHEAL |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 207352 | NANG KUANG PHARM CO |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 216582 | PRINSTON INC |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 204890 | QILU PHARM HAINAN |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 211899 | WAVERLEY PHARMA INC |
| PEMETREXED DISODIUM | PEMETREXED DISODIUM | EQ 100MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription | No | AP | 214073 | ZYDUS PHARMS |