FDA.reportPublic FDA data

Application 210692

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATOVAQUONEATOVAQUONESUSPENSION;ORAL750MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0898AtovaquoneAtovaquonePAI Holdings, LLCANDACurrent
0121-0898AtovaquoneAtovaquonePharmaceutical Associates, Inc.ANDACurrent
0121-0898AtovaquoneAtovaquonePharmaceutical Associates, Inc.ANDACurrent
0121-0898AtovaquoneAtovaquonePharmaceutical Associates, Inc.ANDACurrent
0121-1796AtovaquoneAtovaquonePAI Holdings, LLCANDACurrent
0121-1796AtovaquoneAtovaquonePharmaceutical Associates, Inc.ANDACurrent
0904-7064AtovaquoneAtovaquoneMajor PharmaceuticalsANDACurrent
0904-7064AtovaquoneAtovaquoneMajor PharmaceuticalsANDACurrent
31722-629AtovaquoneAtovaquoneCamber Pharmaceuticals, Inc.ANDACurrent
50268-086AtovaquoneAtovaquoneAvPAKANDACurrent
50268-086AtovaquoneAtovaquoneAvPAKANDACurrent
60687-534AtovaquoneAtovaquoneAmerican Health PackagingANDACurrent
70166-488AtovaquoneAtovaquoneLohxaANDACurrent
70748-299ATOVAQUONEATOVAQUONELupin Pharmaceuticals, Inc.ANDACurrent