NDC 43598-358

Abiraterone Acetate

Abiraterone Acetate

Abiraterone Acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddys Laboratories Inc. The primary component is Abiraterone Acetate.

Product ID43598-358_ba9a1b32-1c07-19be-dfaf-cea4a1d37e73
NDC43598-358
Product TypeHuman Prescription Drug
Proprietary NameAbiraterone Acetate
Generic NameAbiraterone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-05-19
Marketing CategoryANDA /
Application NumberANDA208416
Labeler NameDr. Reddys Laboratories Inc
Substance NameABIRATERONE ACETATE
Active Ingredient Strength250 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 Through2021-12-31

Packaging

NDC 43598-358-04

120 TABLET in 1 BOTTLE (43598-358-04)
Marketing Start Date2020-05-19
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
42291-024Abiraterone AcetateAbiraterone
51407-181Abiraterone Acetateabiraterone acetate
57894-155Abiraterone acetateAbiraterone acetate
57894-199Abiraterone acetateAbiraterone acetate
60505-4327Abiraterone AcetateAbiraterone Acetate
64679-021Abiraterone acetateAbiraterone acetate
69238-1165Abiraterone AcetateAbiraterone
64980-418Abiraterone acetateAbiraterone acetate
0378-6924Abiraterone Acetateabiraterone acetate
60687-455Abiraterone AcetateAbiraterone
72606-566Abiraterone acetateAbiraterone acetate
16714-963Abiraterone AcetateAbiraterone Acetate
43598-358Abiraterone AcetateAbiraterone Acetate
0143-9597AbirateroneAbiraterone acetate
69539-049AbirateroneAbiraterone acetate
72205-030AbirateroneAbiraterone acetate
47335-401YONSAabiraterone acetate
57894-150Zytigaabiraterone acetate
57894-195ZytigaAbiraterone acetate

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.