Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210428
Company: SPIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KAPSPARGO SPRINKLE METOPROLOL SUCCINATE EQ 25MG TARTRATE CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
KAPSPARGO SPRINKLE METOPROLOL SUCCINATE EQ 50MG TARTRATE CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
KAPSPARGO SPRINKLE METOPROLOL SUCCINATE EQ 100MG TARTRATE CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
KAPSPARGO SPRINKLE METOPROLOL SUCCINATE EQ 200MG TARTRATE CAPSULE, EXTENDED RELEASE;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
01/26/2018 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s000lblReplacement.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210428Orig1s000Replacementltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210428Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2018 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/14/2018 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s001lbl.pdf
05/14/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s001lbl.pdf
01/26/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s000lblReplacement.pdf

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