FDA.reportPublic FDA data

Application 208327

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABIRATERONE ACETATEABIRATERONE ACETATETABLET;ORAL250MGNoNo
002ABIRATERONE ACETATEABIRATERONE ACETATETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-024Abiraterone AcetateAbirateroneAvKAREANDACurrent
42291-024Abiraterone AcetateAbirateroneAvKAREANDACurrent
42291-024Abiraterone AcetateAbirateroneAvKARE, Inc.ANDACurrent
42291-073ABIRATERONE ACETATEABIRATERONEAvKAREANDACurrent
42291-073ABIRATERONE ACETATEABIRATERONEAvKAREANDACurrent
60687-455Abiraterone AcetateAbirateroneAmerican Health PackagingANDACurrent
60687-455Abiraterone AcetateAbirateroneAmerican Health PackagingANDACurrent
60687-455Abiraterone AcetateAbirateroneAmerican Health PackagingANDACurrent
60687-455Abiraterone AcetateAbirateroneAmerican Health PackagingANDACurrent
69238-1165Abiraterone AcetateAbirateroneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1165Abiraterone AcetateAbirateroneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1165Abiraterone AcetateAbirateroneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1165Abiraterone AcetateAbirateroneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1165Abiraterone AcetateAbirateroneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1165Abiraterone AcetateAbirateroneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1165Abiraterone AcetateAbirateroneAmneal Pharmaceuticals NY LLCANDACurrent
69238-1165Abiraterone AcetateAbirateroneAmneal Pharmaceuticals LLCANDACurrent
69238-1754ABIRATERONE ACETATEABIRATERONEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1754ABIRATERONE ACETATEABIRATERONEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1754ABIRATERONE ACETATEABIRATERONEAmneal Pharmaceuticals NY LLCANDACurrent
69238-1754ABIRATERONE ACETATEABIRATERONEAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50336ORIG2017-11-08