Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 02/11/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/02/2010 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/089338s036lbl.pdf | |
| 03/31/2003 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/10/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/17/2000 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/04/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/16/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/12/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/17/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/02/2010 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/089338s036lbl.pdf |
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 |