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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065047
Company: HIKMA FARMACEUTICA

Products on ANDA 065047

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065047

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/2025	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
08/21/2025	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
08/21/2025	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
08/21/2025	SUPPL-16	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065047

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 ANTIBIOTICS
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062831	SANDOZ

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