Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202960
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-Container/Carton Labels, Labeling-Package Insert

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 202960 AMNEAL PHARMS
ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription No AB 209750 APOTEX
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
ATOVAQUONE ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription No AB 207833 PADDOCK LLC
MEPRON ATOVAQUONE 750MG/5ML SUSPENSION;ORAL Prescription Yes AB 020500 GLAXOSMITHKLINE LLC

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