Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021314
Company: EXALENZ BIOSCIENCE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IDKIT:HP CITRIC ACID; UREA C-13 N/A,4GM;75MG,N/A FOR SOLUTION, TABLET, FOR SOLUTION;ORAL Prescription None Yes 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
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.

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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