Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020785
Company: BRISTOL-MYERS
Company: BRISTOL-MYERS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THALOMID | THALIDOMIDE | 50MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| THALOMID | THALIDOMIDE | 100MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| THALOMID | THALIDOMIDE | 200MG | CAPSULE;ORAL | Prescription | None | Yes | Yes |
| THALOMID | THALIDOMIDE | 150MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/16/1998 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20785lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20785ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020785s000_ThalidomideTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2023 | SUPPL-71 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020785s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020785Orig1s071ltr.pdf | |
| 08/05/2021 | SUPPL-70 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020785Orig1s070ltr.pdf |
| 02/25/2021 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020785s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020785orig1s069ltr.pdf | |
| 12/04/2019 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020785s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020785Orig1s068ltr.pdf | |
| 06/07/2019 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020785s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020785Orig1s067ltr.pdf | |
| 12/29/2017 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020785Orig1s065ltr.pdf | |
| 11/30/2017 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020785Orig1s064ltr.pdf | |
| 06/27/2017 | SUPPL-63 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020785Orig1s063ltr.pdf |
| 01/27/2017 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020785Orig1s061ltr.pdf | |
| 04/22/2016 | SUPPL-60 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020785Orig1s060ltr.pdf |
| 12/01/2015 | SUPPL-59 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s059ltr.pdf |
| 10/27/2015 | SUPPL-58 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s058ltr.pdf |
| 09/13/2015 | SUPPL-57 | REMS, REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s057ltr.pdf |
| 06/19/2014 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020785s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020785Orig1s055ltr.pdf | |
| 09/12/2014 | SUPPL-54 | REMS-Proposal |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020785Orig1s054ltr.pdf |
| 08/05/2015 | SUPPL-51 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020785s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s051ltr.pdf | |
| 11/15/2013 | SUPPL-50 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020785Orig1s050ltr.pdf |
| 02/08/2013 | SUPPL-48 | REMS-Modified, REMS-Assessment |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020785s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020785Orig1s048ltr.pdf | |
| 02/03/2012 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf | |
| 02/03/2012 | SUPPL-40 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf | |
| 08/03/2010 | SUPPL-39 | REMS-Proposal, Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020785s039ltr.pdf |
| 02/03/2012 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf | |
| 01/10/2007 | SUPPL-32 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020785s032_ltr.pdf |
| 05/25/2006 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021430s000,020785s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021430s000, 020785s031LTR.pdf | |
| 03/05/2004 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20785slr025,026ltr.pdf |
| 03/05/2004 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20785slr025,026ltr.pdf |
| 10/27/2003 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr.pdf | |
| 10/27/2003 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr.pdf | |
| 10/27/2003 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr.pdf | |
| 01/17/2003 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785scf020,021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020785_S021_THALOMID.pdf | |
| 01/17/2003 | SUPPL-20 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785scf020,021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020785_S020_THALOMID.pdf | |
| 11/16/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/2001 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/2001 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20785s12s14ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf | |
| 09/04/2001 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20785s12s14ltr.pdf | |
| 04/03/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1999 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/12/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/24/2023 | SUPPL-71 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020785s071lbl.pdf | |
| 02/25/2021 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020785s069lbl.pdf | |
| 12/04/2019 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020785s068lbl.pdf | |
| 06/07/2019 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020785s067lbl.pdf | |
| 12/29/2017 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s065lbl.pdf | |
| 11/30/2017 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s064lbl.pdf | |
| 01/27/2017 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s061lbl.pdf | |
| 08/05/2015 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020785s051lbl.pdf | |
| 08/05/2015 | SUPPL-51 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020785s051lbl.pdf | |
| 06/19/2014 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020785s055lbl.pdf | |
| 02/08/2013 | SUPPL-48 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020785s048lbl.pdf | |
| 02/08/2013 | SUPPL-48 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020785s048lbl.pdf | |
| 02/03/2012 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf | |
| 02/03/2012 | SUPPL-40 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf | |
| 02/03/2012 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf | |
| 05/25/2006 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021430s000,020785s031lbl.pdf | |
| 10/27/2003 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf | |
| 10/27/2003 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf | |
| 10/27/2003 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf | |
| 01/17/2003 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf | |
| 01/17/2003 | SUPPL-20 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf | |
| 09/04/2001 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf | |
| 09/04/2001 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf | |
| 07/16/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20785lbl.pdf |
THALOMID
CAPSULE;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| THALOMID | THALIDOMIDE | 150MG | CAPSULE;ORAL | Prescription | Yes | AB | 020785 | BRISTOL-MYERS |