Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021880
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REVLIMID | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| REVLIMID | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| REVLIMID | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| REVLIMID | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| REVLIMID | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| REVLIMID | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 12/27/2005 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021880lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021880rev2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021880s000_RevlimidTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2023 | SUPPL-67 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021880s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021880Orig1s067ltr.pdf | |
| 05/24/2022 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021880s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021880Orig1s065ltr.pdf | |
| 08/31/2021 | SUPPL-64 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021880Orig1s064lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021880Orig1s064_REPLACEMENT_ltr.pdf | |
| 08/05/2021 | SUPPL-63 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021880Orig1s063ltr.pdf |
| 10/30/2019 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021880Orig1s060ltr.pdf | |
| 05/28/2019 | SUPPL-57 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021880Orig1s057ltr.pdf | |
| 01/22/2019 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021880Orig1s056ltr.pdf | |
| 12/29/2017 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s055ltr.pdf | |
| 09/24/2020 | SUPPL-54 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021880orig1s054ltr.pdf |
| 11/30/2017 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s052s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s052,021880Orig1s053ltr.pdf | |
| 11/30/2017 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s052s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s052,021880Orig1s053ltr.pdf | |
| 09/15/2017 | SUPPL-51 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s051ltr.pdf | |
| 06/27/2017 | SUPPL-50 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s050ltr.pdf |
| 02/22/2017 | SUPPL-49 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s049ltr.pdf | |
| 04/22/2016 | SUPPL-47 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021880Orig1s047ltr.pdf |
| 12/01/2015 | SUPPL-46 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s046ltr.pdf |
| 10/27/2015 | SUPPL-45 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s045ltr.pdf |
| 09/13/2015 | SUPPL-44 | REMS, REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s044ltr.pdf |
| 02/17/2015 | SUPPL-41 | Efficacy-New Indication, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021880s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s041ltr.pdf | |
| 09/12/2014 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021880s039s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021880Orig1s039,s040ltr.pdf | |
| 09/12/2014 | SUPPL-39 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021880s039s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021880Orig1s039,s040ltr.pdf | |
| 11/04/2013 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s038ltr.pdf | |
| 12/19/2013 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/2013 | SUPPL-35 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s035ltr.pdf |
| 06/05/2013 | SUPPL-34 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s034ltr.pdf | |
| 02/08/2013 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s029,s033ltr.pdf | |
| 05/09/2012 | SUPPL-31 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021880s031ltr.pdf | |
| 02/08/2013 | SUPPL-29 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021880Orig1s029,s033ltr.pdf | |
| 03/12/2012 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021880s028ltr.pdf | |
| 12/21/2011 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021880s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021880s023ltr.pdf | |
| 10/12/2010 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021880s018ltr.pdf | |
| 02/23/2009 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,021880s017ltr.pdf | |
| 02/23/2009 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,021880s017ltr.pdf | |
| 08/03/2010 | SUPPL-13 | REMS-Proposal, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021880s013ltr.pdf | |
| 02/23/2009 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021880s006,021880s016,021880s017ltr.pdf | |
| 06/29/2006 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021880s001.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021880s001LTR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/24/2023 | SUPPL-67 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021880s067lbl.pdf | |
| 05/24/2022 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021880s065lbl.pdf | |
| 08/31/2021 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021880Orig1s064lbledt.pdf | |
| 08/31/2021 | SUPPL-64 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021880Orig1s064lbledt.pdf | |
| 10/30/2019 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s060lbl.pdf | |
| 05/28/2019 | SUPPL-57 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s057lbl.pdf | |
| 01/22/2019 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s056lbl.pdf | |
| 12/29/2017 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s055lbl.pdf | |
| 11/30/2017 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s052s053lbl.pdf | |
| 11/30/2017 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s052s053lbl.pdf | |
| 09/15/2017 | SUPPL-51 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s051lbl.pdf | |
| 02/22/2017 | SUPPL-49 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s049lbl.pdf | |
| 02/17/2015 | SUPPL-41 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021880s041lbl.pdf | |
| 02/17/2015 | SUPPL-41 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021880s041lbl.pdf | |
| 09/12/2014 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021880s039s040lbl.pdf | |
| 09/12/2014 | SUPPL-39 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021880s039s040lbl.pdf | |
| 11/04/2013 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s038lbl.pdf | |
| 06/05/2013 | SUPPL-34 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s034lbl.pdf | |
| 02/08/2013 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf | |
| 02/08/2013 | SUPPL-29 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s029s033lbl.pdf | |
| 05/09/2012 | SUPPL-31 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s031lbl.pdf | |
| 03/12/2012 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021880s028lbl.pdf | |
| 12/21/2011 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021880s023lbl.pdf | |
| 10/12/2010 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s018lbl.pdf | |
| 08/03/2010 | SUPPL-13 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s013lbl.pdf | |
| 08/03/2010 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021880s013lbl.pdf | |
| 02/23/2009 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf | |
| 02/23/2009 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf | |
| 02/23/2009 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021880s006s016s017lbl.pdf | |
| 06/29/2006 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021880s001.pdf | |
| 12/27/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021880lbl.pdf |
REVLIMID
CAPSULE;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 211022 | APOTEX |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 201452 | ARROW INTL |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 215759 | BIOCON PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 210435 | CIPLA |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 217554 | DEVA HOLDING AS |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 209348 | DR REDDYS |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 213885 | EUGIA PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 212414 | HETERO LABS LTD V |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 210480 | LOTUS PHARM CO LTD |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 214398 | LUPIN LTD |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 213912 | MYLAN |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 217281 | NOVUGEN |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 211846 | SUN PHARM |
| LENALIDOMIDE | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 210154 | ZYDUS PHARMS |
| REVLIMID | LENALIDOMIDE | 5MG | CAPSULE;ORAL | Prescription | Yes | AB | 021880 | BRISTOL MYERS SQUIBB |
CAPSULE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 211022 | APOTEX |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 201452 | ARROW INTL |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 215759 | BIOCON PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 210435 | CIPLA |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 217554 | DEVA HOLDING AS |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 209348 | DR REDDYS |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 213885 | EUGIA PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 212414 | HETERO LABS LTD V |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 210480 | LOTUS PHARM CO LTD |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 214398 | LUPIN LTD |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 213912 | MYLAN |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 217281 | NOVUGEN |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 211846 | SUN PHARM |
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 210154 | ZYDUS PHARMS |
| REVLIMID | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 021880 | BRISTOL MYERS SQUIBB |
CAPSULE;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 211022 | APOTEX |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 201452 | ARROW INTL |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 215759 | BIOCON PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 210435 | CIPLA |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 217554 | DEVA HOLDING AS |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 209348 | DR REDDYS |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 213885 | EUGIA PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 212414 | HETERO LABS LTD V |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 210480 | LOTUS PHARM CO LTD |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 214398 | LUPIN LTD |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 213912 | MYLAN |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 217281 | NOVUGEN |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 211846 | SUN PHARM |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 213405 | TORRENT |
| LENALIDOMIDE | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | No | AB | 210154 | ZYDUS PHARMS |
| REVLIMID | LENALIDOMIDE | 15MG | CAPSULE;ORAL | Prescription | Yes | AB | 021880 | BRISTOL MYERS SQUIBB |
CAPSULE;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211022 | APOTEX |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 201452 | ARROW INTL |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 215759 | BIOCON PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 210435 | CIPLA |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 217554 | DEVA HOLDING AS |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 209348 | DR REDDYS |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 213885 | EUGIA PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 212414 | HETERO LABS LTD V |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 210480 | LOTUS PHARM CO LTD |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 214398 | LUPIN LTD |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 213912 | MYLAN |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 217281 | NOVUGEN |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211846 | SUN PHARM |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 210154 | ZYDUS PHARMS |
| REVLIMID | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 021880 | BRISTOL MYERS SQUIBB |
CAPSULE;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 211022 | APOTEX |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 201452 | ARROW INTL |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 215759 | BIOCON PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 214618 | CIPLA |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 217554 | DEVA HOLDING AS |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 209348 | DR REDDYS |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 213885 | EUGIA PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 212414 | HETERO LABS LTD V |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 210480 | LOTUS PHARM CO LTD |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 214398 | LUPIN LTD |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 213912 | MYLAN |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 217281 | NOVUGEN |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 211846 | SUN PHARM |
| LENALIDOMIDE | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | No | AB | 210154 | ZYDUS PHARMS |
| REVLIMID | LENALIDOMIDE | 2.5MG | CAPSULE;ORAL | Prescription | Yes | AB | 021880 | BRISTOL MYERS SQUIBB |
CAPSULE;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 211022 | APOTEX |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 201452 | ARROW INTL |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 215759 | BIOCON PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 210435 | CIPLA |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 217554 | DEVA HOLDING AS |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 209348 | DR REDDYS |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 213885 | EUGIA PHARMA |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 212414 | HETERO LABS LTD V |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 210480 | LOTUS PHARM CO LTD |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 214398 | LUPIN LTD |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 213912 | MYLAN |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 217281 | NOVUGEN |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 211846 | SUN PHARM |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 210154 | ZYDUS PHARMS |
| REVLIMID | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Prescription | Yes | AB | 021880 | BRISTOL MYERS SQUIBB |