Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204372
Company: NOVAST LABS
Company: NOVAST LABS
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 |
---|---|---|---|---|---|---|---|
07/22/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204372Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/11/2019 | SUPPL-1 | Labeling-Package Insert |
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 |
---|---|---|---|---|---|---|---|---|
QUALAQUIN | QUININE SULFATE | 324MG | CAPSULE;ORAL | Prescription | Yes | AB | 021799 | SUN PHARM INDUSTRIES |
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 |