Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212589
Company: EYWA
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 |