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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019481
Company: UNITED GUARDIAN

Products on NDA 019481

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019481

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-Package Insert, Labeling-Container/Carton Labels	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.

Labels for NDA 019481

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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