FDA.reportPublic FDA data

Application 202552

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACITRETINACITRETINCAPSULE;ORAL10MGNoNo
002ACITRETINACITRETINCAPSULE;ORAL17.5MGNoNo
003ACITRETINACITRETINCAPSULE;ORAL22.5MGNoNo
004ACITRETINACITRETINCAPSULE;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1667AcitretinAcitretinImpax GenericsANDACurrent
0115-1668AcitretinAcitretinImpax GenericsANDACurrent
0115-1669AcitretinAcitretinImpax GenericsANDACurrent
0115-1698AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1698AcitretinAcitretinImpax GenericsANDACurrent
0115-1698AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1750AcitretinAcitretinImpax GenericsANDACurrent
0115-1750AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1750AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1750AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1751AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1751AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1751AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1751AcitretinAcitretinImpax GenericsANDACurrent
0115-1752AcitretinAcitretinImpax GenericsANDACurrent
0115-1752AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1752AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1752AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1753AcitretinAcitretinImpax GenericsANDACurrent
0115-1753AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1753AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1753AcitretinAcitretinAmneal Pharmaceuticals of New York LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32273ORIG2015-12-29