FDA NDA · NDA204078

BLOXIVERZ

neostigmine methylsulfate

Sponsor: EXELA PHARMA

APPLICATION

NDA204078

TYPE

NDA

ORIGINAL APPROVAL

2013-05-31

LATEST ACTION

2023-10-27

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

BLOXIVERZ · ReferenceDiscontinued

NEOSTIGMINE METHYLSULFATE 5MG/5ML (1MG/ML) · SOLUTION · INTRAVENOUS

BLOXIVERZ · ReferenceDiscontinued

NEOSTIGMINE METHYLSULFATE 5MG/10ML (0.5MG/ML) · SOLUTION · INTRAVENOUS

BLOXIVERZ · ReferenceDiscontinued

NEOSTIGMINE METHYLSULFATE 10MG/10ML (1MG/ML) · SOLUTION · INTRAVENOUS

2023-10-27Manufacturing (CMC) · Supplement 14 — Letter ↗AP

2021-01-19Labeling · Supplement 10 · standard — Letter ↗AP

2015-10-20Labeling · Supplement 7 · standard — Label ↗AP

2014-12-11Labeling · Supplement 4 · standard — Label ↗AP

2014-12-02Manufacturing (CMC) · Supplement 6 · standardAP

2014-09-30Manufacturing (CMC) · Supplement 5 · standardAP

2014-09-22Manufacturing (CMC) · Supplement 3 · standardAP

2014-06-18Manufacturing (CMC) · Supplement 1 · standardAP

2013-05-31Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP

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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