Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065141
Company: SAMSON MEDCL

Products on ANDA 065141

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 100GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	No	Yes
CEFAZOLIN SODIUM	CEFAZOLIN SODIUM	EQ 300GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065141

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2006	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
09/28/2018	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/28/2018	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/30/2013	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065141s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/065141Orig1s003ltr.pdf

Labels for ANDA 065141

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2013	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065141s003lbl.pdf