Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075020
Company: BARR LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYUREA HYDROXYUREA 500MG CAPSULE;ORAL Discontinued None 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
07/30/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75020_Hydroxyurea.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/13/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

06/26/2000 SUPPL-2 Labeling

Label is not available on this site.

06/26/2000 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

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