FDA.reportPublic FDA data

Application 205618

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALIPERIDONEPALIPERIDONETABLET, EXTENDED RELEASE;ORAL1.5mgNoNo
002PALIPERIDONEPALIPERIDONETABLET, EXTENDED RELEASE;ORAL3MGNoNo
003PALIPERIDONEPALIPERIDONETABLET, EXTENDED RELEASE;ORAL6MGNoNo
004PALIPERIDONEPALIPERIDONETABLET, EXTENDED RELEASE;ORAL9MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6935PaliperidonePaliperidoneMajor PharmaceuticalsANDACurrent
0904-6935PaliperidonePaliperidoneMajor PharmaceuticalsANDACurrent
0904-6935PaliperidonePaliperidoneMajor PharmaceuticalsANDACurrent
0904-6936PaliperidonePaliperidoneMajor PharmaceuticalsANDACurrent
0904-6936PaliperidonePaliperidoneMajor PharmaceuticalsANDACurrent
0904-6936PaliperidonePaliperidoneMajor PharmaceuticalsANDACurrent
0904-6937PaliperidonePaliperidoneMajor PharmaceuticalsANDACurrent
0904-6937PaliperidonePaliperidoneMajor PharmaceuticalsANDACurrent
0904-6937PaliperidonePaliperidoneMajor PharmaceuticalsANDACurrent
16714-866PaliperidonePaliperidoneNorthStar RxLLCANDACurrent
16714-866PaliperidonePaliperidoneNorthStar RxLLCANDACurrent
16714-867PaliperidonePaliperidoneNorthStar RxLLCANDACurrent
16714-867PaliperidonePaliperidoneNorthStar RxLLCANDACurrent
16714-868PaliperidonePaliperidoneNorthStar RxLLCANDACurrent
16714-868PaliperidonePaliperidoneNorthStar RxLLCANDACurrent
16714-869PaliperidonePaliperidoneNorthStar RxLLCANDACurrent
16714-869PaliperidonePaliperidoneNorthStar RxLLCANDACurrent
47335-744PaliperidonePaliperidoneSun Pharmaceutical Industries, Inc.ANDACurrent
47335-744PaliperidonePaliperidoneSun Pharmaceutical Industries, Inc.ANDACurrent
47335-765PaliperidonePaliperidoneSun Pharmaceutical Industries, Inc.ANDACurrent
47335-765PaliperidonePaliperidoneSun Pharmaceutical Industries, Inc.ANDACurrent
47335-766PaliperidonePaliperidoneSun Pharmaceutical Industries, Inc.ANDACurrent
47335-766PaliperidonePaliperidoneSun Pharmaceutical Industries, Inc.ANDACurrent
47335-767PaliperidonePaliperidoneSun Pharmaceutical Industries, Inc.ANDACurrent
47335-767PaliperidonePaliperidoneSun Pharmaceutical Industries, Inc.ANDACurrent
60687-459PaliperidonePaliperidoneAmerican Health PackagingANDACurrent
60687-459PaliperidonePaliperidoneAmerican Health PackagingANDACurrent
60687-470PaliperidonePaliperidoneAmerican Health PackagingANDACurrent
60687-470PaliperidonePaliperidoneAmerican Health PackagingANDACurrent