FDA.reportPublic FDA data

Application 200895

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIMVASTATINSIMVASTATINTABLET;ORAL5MGNoNo
002SIMVASTATINSIMVASTATINTABLET;ORAL10MGNoNo
003SIMVASTATINSIMVASTATINTABLET;ORAL20MGNoNo
004SIMVASTATINSIMVASTATINTABLET;ORAL40MGNoNo
005SIMVASTATINSIMVASTATINTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-510SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-510SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-510SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-511SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-511SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-511SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-512SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-512SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-512SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-513SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-513SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-513SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-514SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-514SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
31722-514SimvastatinSimvastatinCamber Pharmaceuticals, Inc.ANDACurrent
50090-3922SimvastatinSimvastatinA-S Medication SolutionsANDACurrent
50090-3922SimvastatinSimvastatinA-S Medication SolutionsANDACurrent
68071-3115SimvastatinSimvastatinNuCare Pharmaceuticals, Inc.ANDACurrent
70934-376SimvastatinSimvastatinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-376SimvastatinSimvastatinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
82009-012SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-012SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-012SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-012SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-013SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-013SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-013SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-013SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-014SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-014SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-014SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-014SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-015SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-015SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-015SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-015SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-016SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-016SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-016SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent
82009-016SimvastatinSimvastatinQuallent Pharmaceuticals Health LLCANDACurrent