U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075143
Company: BARR

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYUREA HYDROXYUREA 500MG CAPSULE;ORAL Prescription AB No No
HYDROXYUREA HYDROXYUREA 250MG CAPSULE;ORAL Discontinued None No 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
10/16/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75143ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75143_Hydroxyurea.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/23/2024 SUPPL-29 Labeling-Container/Carton Labels

Label is not available on this site.
09/23/2024 SUPPL-28 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.
09/23/2024 SUPPL-27 Labeling-Package Insert

Label is not available on this site.
09/23/2024 SUPPL-24 Labeling-Package Insert

Label is not available on this site.
09/23/2024 SUPPL-22 Labeling-Package Insert

Label is not available on this site.
09/23/2024 SUPPL-21 Labeling-Package Insert

Label is not available on this site.
09/23/2024 SUPPL-20 Labeling-Package Insert

Label is not available on this site.
02/27/2013 SUPPL-17 Labeling-Package Insert

Label is not available on this site.
02/27/2013 SUPPL-16 Labeling-Container/Carton Labels

Label is not available on this site.
11/14/2011 SUPPL-15 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
08/15/2006 SUPPL-14 Labeling

Label is not available on this site.
04/28/2005 SUPPL-12 Labeling

Label is not available on this site.
09/27/2001 SUPPL-9 Labeling

Label is not available on this site.
05/24/2000 SUPPL-8 Labeling

Label is not available on this site.
12/21/1999 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.
09/21/2000 SUPPL-6 Labeling

Label is not available on this site.
09/21/2000 SUPPL-5 Manufacturing (CMC)-New Strength

Label is not available on this site.
05/13/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
05/13/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
05/20/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
03/23/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

HYDROXYUREA

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 CHEPLAPHARM
HYDROXYUREA HYDROXYUREA 500MG CAPSULE;ORAL Prescription No AB 075143 BARR
HYDROXYUREA HYDROXYUREA 500MG CAPSULE;ORAL Prescription No AB 075340 ENDO OPERATIONS
HYDROXYUREA HYDROXYUREA 500MG CAPSULE;ORAL Prescription No AB 213438 LEADING
HYDROXYUREA HYDROXYUREA 500MG CAPSULE;ORAL Prescription No AB 218021 QILU
Back to Top