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FDA NDA · NDA212862

PRETOMANID

Sponsor: MYLAN IRELAND LTD

APPLICATION
NDA212862
TYPE
NDA
ORIGINAL APPROVAL
2019-08-14
LATEST ACTION
2024-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PRETOMANID · ReferencePrescription
PRETOMANID 200MG · TABLET · ORAL

Approval history

2024-11-22Efficacy · Supplement 8 · standard — Label ↗AP
2022-12-21Labeling · Supplement 4 · standard — Letter ↗AP
2019-08-14Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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