Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019481
Company: UNITED GUARDIAN
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. |
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02/12/2014 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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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. |
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08/31/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/28/1996 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/03/1993 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/13/1993 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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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 |