Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016295
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DROXIA HYDROXYUREA 200MG CAPSULE;ORAL Prescription None Yes No
DROXIA HYDROXYUREA 300MG CAPSULE;ORAL Prescription None Yes No
DROXIA HYDROXYUREA 400MG CAPSULE;ORAL Prescription None Yes No
HYDREA HYDROXYUREA 500MG CAPSULE;ORAL Prescription AB 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
12/07/1967 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/22/2019 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016295s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016295Orig1s051ltr.pdf
12/18/2017 SUPPL-50 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016295Orig1s049,s050ltr.pdf
12/18/2017 SUPPL-49 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016295Orig1s049,s050ltr.pdf
03/23/2016 SUPPL-48 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf
03/23/2016 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016295Orig1s047,s048ltr.pdf
07/16/2015 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s046ltr.pdf
07/16/2015 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s045ltr.pdf
01/26/2012 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf
01/26/2012 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf
05/07/2010 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016295s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016295s040ltr.pdf
09/19/2006 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016295s039s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016295s039, 016295s036ltr.pdf
02/19/2004 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16295slr037_hydrea_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16295slr037ltr.pdf
06/26/2003 SUPPL-36 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16295se2-036_droxia_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16295se2-036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/16-295S036_Droxia.cfm
02/20/2001 SUPPL-35 Labeling

Label is not available on this site.

04/04/2001 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16295S34ltr.pdf
01/12/2000 SUPPL-33 Labeling

Label is not available on this site.

11/10/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1998 SUPPL-29 Efficacy-New Indication

Label is not available on this site.

05/23/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/11/1999 SUPPL-26 Labeling

Label is not available on this site.

11/25/1996 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/15/1996 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1996 SUPPL-23 Labeling

Label is not available on this site.

03/09/1993 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/31/1992 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/1995 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1988 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1988 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/19/1987 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/19/1987 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1996 SUPPL-11 Labeling

Label is not available on this site.

02/19/1980 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1977 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/22/2019 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016295s051lbl.pdf
12/18/2017 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf
12/18/2017 SUPPL-50 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf
12/18/2017 SUPPL-49 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf
12/18/2017 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf
03/23/2016 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf
03/23/2016 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf
07/16/2015 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s046lbl.pdf
07/16/2015 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s045lbl.pdf
01/26/2012 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf
01/26/2012 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf
05/07/2010 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016295s040lbl.pdf
09/19/2006 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016295s039s036lbl.pdf
02/19/2004 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16295slr037_hydrea_lbl.pdf
06/26/2003 SUPPL-36 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16295se2-036_droxia_lbl.pdf

DROXIA

There are no Therapeutic Equivalents.

HYDREA

CAPSULE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDREA HYDROXYUREA 500MG CAPSULE;ORAL Prescription Yes AB 016295 BRISTOL MYERS SQUIBB
HYDROXYUREA HYDROXYUREA 500MG CAPSULE;ORAL Prescription No AB 075143 BARR
HYDROXYUREA HYDROXYUREA 500MG CAPSULE;ORAL Prescription No AB 075340 PAR PHARM

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