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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062807
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 5GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE;INJECTION 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
01/12/1988 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/24/1991 SUPPL-5 Labeling

Label is not available on this site.
10/25/1990 SUPPL-3 Labeling

Label is not available on this site.
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