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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021314
Company: MERIDIAN BIOSCIENCE

Products on NDA 021314

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IDKIT:HP	CITRIC ACID; UREA C-13	4GM;75MG	FOR SOLUTION, TABLET, FOR SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021314

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21314_BreathID_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21314ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021314s000_IDKitTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/08/2016	SUPPL-5	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021314Orig1s005ltr.pdf
10/28/2014	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021314s004.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021314Orig1s004ltr.pdf
01/18/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/26/2010	SUPPL-2	Labeling		Label is not available on this site.

Labels for NDA 021314

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2014	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021314s004.pdf
12/17/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21314_BreathID_lbl.pdf

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