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FDA NDA · NDA208574

ROMIDEPSIN

Sponsor: TEVA PHARMS USA INC

APPLICATION
NDA208574
TYPE
NDA
ORIGINAL APPROVAL
2020-03-13
LATEST ACTION
2021-12-08
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ROMIDEPSIN · ReferenceDiscontinued
ROMIDEPSIN 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
ROMIDEPSIN · ReferenceDiscontinued
ROMIDEPSIN 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2021-12-08Labeling · Supplement 6 · standard — Letter ↗AP
2020-03-13Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
2020-03-13Efficacy · Original · standard — Label ↗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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