FDA Orange Book · active-ingredient family
Quinidine sulfate
Quinidine sulfate is approved as 1 brand and 47 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:QUINIDEX · NDA 012796
1
Brand (NDA)
47
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QUINIDEX | WYETH PHARMS INC | NDA 012796 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (47)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QUINIDINE SULFATE | COSETTE | ANDA 040045 | — | Jun 30, 1994 | |
| QUINIDINE SULFATE | SUN PHARM INDUSTRIES | ANDA 081029 | — | Apr 14, 1989 | |
| QUINIDINE SULFATE | SUN PHARM INDUSTRIES | ANDA 081030 | — | Apr 14, 1989 | |
| QUINIDINE SULFATE | SUN PHARM INDUSTRIES | ANDA 081031 | — | Apr 14, 1989 | |
| QUINIDINE SULFATE | CHARTWELL RX | ANDA 089839 | — | Sep 29, 1988 | |
| QUINIDINE SULFATE | SUPERPHARM | ANDA 088973 | — | Apr 10, 1985 | |
| QUINIDINE SULFATE | VANGARD | ANDA 087909 | — | Jul 13, 1982 | |
| QUINIDINE SULFATE | USL PHARMA | ANDA 087837 | — | Apr 14, 1982 | |
| CIN-QUIN | SOLVAY | ANDA 085296 | — | Approved Prior to Jan 1, 1982 | |
| CIN-QUIN | SOLVAY | ANDA 085297 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | LILLY | ANDA 085103 | — | Approved Prior to Jan 1, 1982 | |
| CIN-QUINRLD | SOLVAY | ANDA 085299 | — | Approved Prior to Jan 1, 1982 | |
| CIN-QUINRLD | SOLVAY | ANDA 084932 | — | Approved Prior to Jan 1, 1982 | |
| CIN-QUIN | SOLVAY | ANDA 085298 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | BARR | ANDA 084177 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | CHARTWELL MOLECULAR | ANDA 083743 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | CONTRACT PHARMACAL | ANDA 083808 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | CYCLE | ANDA 083640 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | CYCLE | ANDA 085632 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | DAVA PHARMS INC | ANDA 087011 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | ELKINS SINN | ANDA 083622 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE×2 | EPIC PHARMA LLC | ANDA 088072 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | EVERYLIFE | ANDA 083439 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | HALSEY | ANDA 083583 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | HIKMA | ANDA 083862 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | IMPAX LABS | ANDA 083347 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | IVAX SUB TEVA PHARMS | ANDA 084549 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | KING PHARMS | ANDA 085175 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | KV PHARM | ANDA 085276 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | LEDERLE | ANDA 086176 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | LILLY | ANDA 085038 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | PERRIGO | ANDA 085322 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | PHARMAVITE | ANDA 084627 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | PUREPAC PHARM | ANDA 084003 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | SANDOZ | ANDA 084631 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | SANDOZ | ANDA 084914 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | SCHERER LABS | ANDA 085068 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | VALEANT PHARM INTL | ANDA 083393 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | VINTAGE PHARMS | ANDA 083963 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | WARNER CHILCOTT | ANDA 083879 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | WATSON LABS | ANDA 085584 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | WATSON LABS | ANDA 083288 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | WATSON LABS | ANDA 085140 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | WATSON LABS | ANDA 085583 | — | Approved Prior to Jan 1, 1982 | |
| QUINIDINE SULFATE | WHITEWORTH TOWN PLSN | ANDA 085444 | — | Approved Prior to Jan 1, 1982 | |
| QUINORA | KEY PHARMS | ANDA 083576 | — | Approved Prior to Jan 1, 1982 | |
| QUINORARLD | SCHERING | ANDA 085222 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Quinidine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

