Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091661
Company: TEVA PHARMS
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QUININE SULFATE | QUININE SULFATE | 324MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
09/28/2012 | 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 |
---|---|---|---|---|---|
08/22/2024 | SUPPL-9 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/13/2019 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/17/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
03/10/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
04/22/2013 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
QUININE SULFATE
CAPSULE;ORAL; 324MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUININE SULFATE | QUININE SULFATE | 324MG | CAPSULE;ORAL | Prescription | No | AB | 203729 | AMNEAL PHARMS |
QUININE SULFATE | QUININE SULFATE | 324MG | CAPSULE;ORAL | Prescription | No | AB | 203112 | LUPIN LTD |
QUININE SULFATE | QUININE SULFATE | 324MG | CAPSULE;ORAL | Prescription | No | AB | 204372 | NOVAST LABS |
QUININE SULFATE | QUININE SULFATE | 324MG | CAPSULE;ORAL | Prescription | No | AB | 091661 | TEVA PHARMS |