Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203112
Company: LUPIN LTD
Company: LUPIN LTD
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 |
---|---|---|---|---|---|---|---|
04/24/2015 | ORIG-1 | Approval |
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 |