Drugs@FDA: FDA-Approved Drugs

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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
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-Container/Carton Labels, Labeling-Package Insert

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 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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