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Abbreviated New Drug Application (ANDA): 212589
Company: EYWA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINIDINE GLUCONATE QUINIDINE GLUCONATE 324MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/17/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212589Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/27/2023 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

QUINIDINE GLUCONATE

TABLET, EXTENDED RELEASE;ORAL; 324MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUINIDINE GLUCONATE QUINIDINE GLUCONATE 324MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212589 EYWA
QUINIDINE GLUCONATE QUINIDINE GLUCONATE 324MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 089338 SUN PHARM INDUSTRIES
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