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FDA ANDA · ANDA209227

ABIRATERONE ACETATE

Sponsor: GLENMARK SPECLT

APPLICATION
ANDA209227
TYPE
ANDA
ORIGINAL APPROVAL
2019-10-16
LATEST ACTION
2022-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ABIRATERONE ACETATEPrescription
ABIRATERONE ACETATE 500MG · TABLET · ORAL
ABIRATERONE ACETATEPrescription
ABIRATERONE ACETATE 250MG · TABLET · ORAL

Approval history

2022-05-19Manufacturing (CMC) · Supplement 4 · unknownAP
2021-11-12Labeling · Supplement 3 · standardAP
2021-04-05Labeling · Supplement 2 · standardAP
2019-10-16UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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