NDC 60505-4764

abiraterone acetate

Abiraterone Acetate

abiraterone acetate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Abiraterone Acetate.

Product ID60505-4764_c70c4abf-4fa0-4431-e053-2a95a90a3d46
Product TypeHuman Prescription Drug
Proprietary Nameabiraterone acetate
Generic NameAbiraterone Acetate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2021-07-16
Marketing CategoryANDA /
Application NumberANDA212462
Labeler NameApotex Corp.
Active Ingredient Strength500 mg/1
Pharm ClassesCytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31


NDC 60505-4764-6

60 TABLET, FILM COATED in 1 BOTTLE (60505-4764-6)
Marketing Start Date2021-07-16
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "abiraterone acetate" or generic name "Abiraterone Acetate"

NDCBrand NameGeneric Name
0093-1125Abiraterone AcetateAbiraterone Acetate
0378-6920Abiraterone Acetateabiraterone acetate
0378-6921Abiraterone Acetateabiraterone acetate
0378-6924Abiraterone Acetateabiraterone acetate
0904-6948Abiraterone AcetateAbiraterone Acetate
16714-963Abiraterone AcetateAbiraterone Acetate
42291-024Abiraterone AcetateAbiraterone
42292-057Abiraterone Acetateabiraterone acetate
43598-358Abiraterone AcetateAbiraterone Acetate
51407-181Abiraterone Acetateabiraterone acetate
57894-155Abiraterone acetateAbiraterone acetate
69238-1165Abiraterone AcetateAbiraterone Acetate
57894-199Abiraterone acetateAbiraterone acetate
60505-4327Abiraterone AcetateAbiraterone Acetate
64679-021Abiraterone acetateAbiraterone acetate
64980-418Abiraterone acetateAbiraterone acetate
60687-455Abiraterone AcetateAbiraterone Acetate
72606-566Abiraterone acetateAbiraterone acetate
68462-135abiraterone acetateabiraterone acetate
0143-9597AbirateroneAbiraterone acetate
47335-401YONSAabiraterone acetate
57894-150Zytigaabiraterone acetate

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.