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 |
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 |