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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018907
Company: HIKMA

Products on NDA 018907

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METRONIDAZOLE	METRONIDAZOLE	500MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018907

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/1984	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
12/15/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018907s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018907Orig1s007ltr.pdf
03/05/2021	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018907s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018907Orig1s006ltr.pdf
03/26/1993	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/20/1988	SUPPL-4	Labeling		Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. Label is not available on this site.
12/08/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/03/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018907

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018907s007lbl.pdf
03/05/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018907s006lbl.pdf

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