FDA.reportPublic FDA data

Application 203691

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL5MGNoNo
002TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL20MGNoNo
003TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL100MGNoNo
004TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL140MGNoNo
005TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL180MGNoNo
006TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50268-761TemozolomideTemozolomideAvPAKANDACurrent
50268-761TemozolomideTemozolomideAvPAKANDACurrent
50268-761TemozolomideTemozolomideAvPAKANDACurrent
50268-762TemozolomideTemozolomideAvPAKANDACurrent
50268-762TemozolomideTemozolomideAvPAKANDACurrent
50268-762TemozolomideTemozolomideAvPAKANDACurrent
50268-763TemozolomideTemozolomideAvPAKANDACurrent
65162-801TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-801TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-801TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-801TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-801TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-802TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-802TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-802TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-802TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-802TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-803TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-803TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-803TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-803TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-803TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-804TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-804TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-804TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-804TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-804TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-805TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-805TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-805TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-805TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-805TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-806TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-806TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-806TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-806TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent
65162-806TemozolomideTemozolomideAmneal Pharmaceuticals LLCANDACurrent