Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011642
Company: PHARM RES ASSOC
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 |