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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075340
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYUREA HYDROXYUREA 500MG CAPSULE;ORAL Prescription AB 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
02/24/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75340ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/20/2015 SUPPL-11 Labeling-Container/Carton Labels

Label is not available on this site.

02/27/2013 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

10/11/2011 SUPPL-8 Labeling-Container/Carton Labels

Label is not available on this site.

04/11/2011 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

08/15/2006 SUPPL-3 Labeling

Label is not available on this site.

04/11/2002 SUPPL-2 Labeling

Label is not available on this site.

03/27/2001 SUPPL-1 Labeling

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 213438 LEADING PHARMA LLC
HYDROXYUREA HYDROXYUREA 500MG CAPSULE;ORAL Prescription No AB 075340 PAR PHARM
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