Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065047
Company: HIKMA FARMACEUTICA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/18/2001 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65047ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/065047.pdf

CEFAZOLIN SODIUM

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065303 ACS DOBFAR
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065047 HIKMA FARMACEUTICA
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062831 SANDOZ

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065303 ACS DOBFAR
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065047 HIKMA FARMACEUTICA
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203661 QILU
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062831 SANDOZ
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065345 SANDOZ

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