Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202960
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;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 |
---|---|---|---|---|---|---|---|
03/18/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202960Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/20/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
09/20/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
12/21/2018 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/21/2018 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ATOVAQUONE
SUSPENSION;ORAL; 750MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 210510 | ABHAI LLC |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 214272 | ABON PHARMS LLC |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 202960 | AMNEAL PHARMS |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209750 | APOTEX |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 212918 | BIONPHARMA |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 207833 | CHARTWELL RX |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209685 | GLENMARK PHARMS |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 210692 | HETERO LABS LTD III |
ATOVAQUONE | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209105 | LUPIN LTD |
MEPRON | ATOVAQUONE | 750MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 020500 | GLAXOSMITHKLINE LLC |