FDA.reportPublic FDA data

Application 202508

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTRELLEVONORGESTRELTABLET;ORAL1.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-620LevonorgestrelLevonorgestrelNovel Laboratories, Inc.ANDACurrent
40032-622LevonorgestrelLevonorgestrelNovel Laboratories, Inc.ANDACurrent
43386-620My WayLevonorgestrelGAVIS Pharmaceuticals, LLC.ANDACurrent
43386-622My WayLevonorgestrelLupin Pharmaceuticals,Inc.ANDACurrent
63704-009LevonorgestrelLevonorgestrelPharmacist Pharmaceutical, LLCANDACurrent
63704-010LevonorgestrelLevonorgestrelPharmacist Pharmaceutical, LLCANDACurrent