FDA.reportPublic FDA data

Application 211139

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPHETAMINE SULFATEAMPHETAMINE SULFATETABLET;ORAL5MGNoNo
002AMPHETAMINE SULFATEAMPHETAMINE SULFATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1563Amphetamine SulfateAmphetamineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1563Amphetamine SulfateAmphetamineAmneal Pharmaceuticals LLCANDACurrent
69238-1563Amphetamine SulfateAmphetamineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1563Amphetamine SulfateAmphetamineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1563Amphetamine SulfateAmphetamineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1563Amphetamine SulfateAmphetamineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1564Amphetamine SulfateAmphetamineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1564Amphetamine SulfateAmphetamineAmneal Pharmaceuticals LLCANDACurrent
69238-1564Amphetamine SulfateAmphetamineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1564Amphetamine SulfateAmphetamineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1564Amphetamine SulfateAmphetamineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1564Amphetamine SulfateAmphetamineAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56872ORIG2018-12-20