← FDA DRUG APPROVALS

FDA NDA · NDA208385

DAPTOMYCIN

Sponsor: SAGENT PHARMS INC

APPLICATION
NDA208385
TYPE
NDA
ORIGINAL APPROVAL
2017-09-12
LATEST ACTION
2025-04-30
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

DAPTOMYCIN · ReferencePrescription
DAPTOMYCIN 350MG/VIAL · POWDER · INTRAVENOUS

Approval history

2025-04-30Labeling · Supplement 11 · standard — Letter ↗AP
2022-02-07Labeling · Supplement 7 · standard — Letter ↗AP
2022-02-07Labeling · Supplement 8 · standard — Letter ↗AP
2020-04-03Labeling · Supplement 5 · standard — Letter ↗AP
2018-08-30Labeling · Supplement 1 · standard — Label ↗AP
2017-09-12Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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