Application 211829

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANOLAZINERANOLAZINETABLET, EXTENDED RELEASE;ORAL500MGNoNo
002RANOLAZINERANOLAZINETABLET, EXTENDED RELEASE;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50228-423RANOLAZINERANOLAZINEScieGen Pharmaceuticals, IncANDACurrent
50228-423RANOLAZINERANOLAZINEScieGen Pharmaceuticals, IncANDACurrent
50228-424RANOLAZINERANOLAZINEScieGen Pharmaceuticals, IncANDACurrent
50228-424RANOLAZINERANOLAZINEScieGen Pharmaceuticals, IncANDACurrent
51407-225RANOLAZINERANOLAZINEGolden State Medical Supply Inc.ANDACurrent
51407-225RANOLAZINERANOLAZINEGolden State Medical SupplyANDACurrent
51407-225RANOLAZINERANOLAZINEGolden State Medical SupplyANDACurrent
51407-226RANOLAZINERANOLAZINEGolden State Medical Supply Inc.ANDACurrent
51407-226RANOLAZINERANOLAZINEGolden State Medical SupplyANDACurrent
69367-293RanolazineRanolazineWestminster Pharmaceuticals, LLCANDACurrent
69367-294RanolazineRanolazineWestminster Pharmaceuticals, LLCANDACurrent
71205-867RanolazineRanolazineProficient Rx LPANDACurrent
71205-867RanolazineRanolazineProficient Rx LPANDACurrent
71205-868RanolazineRanolazineProficient Rx LPANDACurrent
71205-868RanolazineRanolazineProficient Rx LPANDACurrent
71610-322RANOLAZINERANOLAZINEAphena Pharma Solutions - Tennessee, LLCANDACurrent