Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019481
Company: UNITED GUARDIAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RENACIDIN CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE 6.602GM/100ML;198MG/100ML;3.177GM/100ML SOLUTION;IRRIGATION 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
10/02/1990 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2015 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019481s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019481Orig1s013ltr.pdf
12/16/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/12/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/03/2007 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019481s007ltr.pdf
09/30/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1993 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/30/2015 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019481s013lbl.pdf

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