Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 011642
Company: PHARM RES ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDIOQUIN QUINIDINE POLYGALACTURONATE 275MG TABLET;ORAL Discontinued None No No
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/16/1999 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/11-642S012_Cardioquin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/11-642S012_Cardioquin_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/11-642s012_Cardioquin.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/16/1999 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/11-642S012_Cardioquin_prntlbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English