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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019071
Company: MISSION PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UROCIT-K POTASSIUM CITRATE 5MEQ TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
UROCIT-K POTASSIUM CITRATE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
UROCIT-K POTASSIUM CITRATE 15MEQ TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/10/2021 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019071s013lbl.pdf
12/10/2021 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019071s013lbl.pdf
12/30/2009 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019071s012lbl.pdf
12/30/2009 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019071s012lbl.pdf
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