Application 205119

Type
ANDA
Sponsor
AMNEAL PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORALEQ 20MG BASENoNo
002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORALEQ 40MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-569Pantoprazole SodiumPantoprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-676Pantoprazole SodiumPantoprazolemedsource pharmaceuticalsANDACurrent
63187-837Pantoprazole SodiumPantoprazoleProficient Rx LPANDACurrent
63187-837Pantoprazole SodiumPantoprazoleProficient Rx LPANDACurrent
63187-837Pantoprazole SodiumPantoprazoleProficient Rx LPANDACurrent
63187-837Pantoprazole SodiumPantoprazoleProficient Rx LPANDACurrent
63187-837Pantoprazole SodiumPantoprazoleProficient Rx LPANDACurrent
63187-837Pantoprazole SodiumPantoprazoleProficient Rx LPANDACurrent
63187-974Pantoprazole SodiumPantoprazoleProficient Rx LPANDACurrent
63187-974Pantoprazole SodiumPantoprazoleProficient Rx LPANDACurrent
65162-636Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-636Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-636Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-636Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-636Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-636Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-636Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-637Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-637Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-637Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-637Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-637Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-637Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-637Pantoprazole SodiumPantoprazoleAmneal Pharmaceuticals LLCANDACurrent
70332-300PANTOPRAZOLE SODIUMPANTOPRAZOLECalifornia Pharmaceuticals LLCANDACurrent
71335-0291Pantoprazole SodiumPantoprazoleBryant Ranch PrepackANDACurrent
71335-0291Pantoprazole SodiumPantoprazoleBryant Ranch PrepackANDACurrent
71335-0291Pantoprazole SodiumPantoprazoleBryant Ranch PrepackANDACurrent
71335-0291Pantoprazole SodiumPantoprazoleBryant Ranch PrepackANDACurrent
80425-0085ProtonixPantoprazole 20mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0085Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0085Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0085Pantoprazole SodiumPantoprazole SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent