Abiraterone Acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Inc.. The primary component is Abiraterone Acetate.
| Product ID | 42292-057_a75b6f73-e703-3da5-e053-2a95a90abec1 |
| NDC | 42292-057 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Abiraterone Acetate |
| Generic Name | Abiraterone Acetate |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-06-03 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA208446 |
| Labeler Name | Mylan Institutional Inc. |
| Substance Name | ABIRATERONE ACETATE |
| Active Ingredient Strength | 250 mg/1 |
| Pharm Classes | Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-06-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA208446 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-06-03 |
| Marketing Category | ANDA |
| Application Number | ANDA208446 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-06-03 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-1125 | Abiraterone Acetate | Abiraterone Acetate |
| 0378-6920 | Abiraterone Acetate | abiraterone acetate |
| 0378-6921 | Abiraterone Acetate | abiraterone acetate |
| 0378-6924 | Abiraterone Acetate | abiraterone acetate |
| 0904-6948 | Abiraterone Acetate | Abiraterone Acetate |
| 16714-963 | Abiraterone Acetate | Abiraterone Acetate |
| 42291-024 | Abiraterone Acetate | Abiraterone |
| 42291-073 | ABIRATERONE ACETATE | ABIRATERONE |
| 42292-057 | Abiraterone Acetate | abiraterone acetate |
| 43598-358 | Abiraterone Acetate | Abiraterone Acetate |
| 69238-1165 | Abiraterone Acetate | Abiraterone Acetate |
| 51407-181 | Abiraterone Acetate | Abiraterone Acetate |
| 57894-199 | Abiraterone acetate | Abiraterone acetate |
| 57894-155 | Abiraterone acetate | Abiraterone acetate |
| 60505-4327 | Abiraterone Acetate | Abiraterone Acetate |
| 64679-021 | Abiraterone acetate | Abiraterone acetate |
| 64980-418 | Abiraterone acetate | Abiraterone acetate |
| 60687-455 | Abiraterone Acetate | Abiraterone Acetate |
| 72606-566 | Abiraterone acetate | Abiraterone acetate |
| 68462-135 | abiraterone acetate | abiraterone acetate |
| 0143-9597 | Abiraterone | Abiraterone acetate |
| 47335-401 | YONSA | abiraterone acetate |