← FDA DRUG APPROVALS

FDA NDA · NDA204300

VAZCULEP

Sponsor: EXELA PHARMA

APPLICATION
NDA204300
TYPE
NDA
ORIGINAL APPROVAL
2014-06-27
LATEST ACTION
2020-03-20
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

VAZCULEP · ReferenceDiscontinued
PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
VAZCULEP · ReferenceDiscontinued
PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
VAZCULEP · ReferenceDiscontinued
PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2020-03-20Labeling · Supplement 11 · standard — Letter ↗AP
2019-10-18Labeling · Supplement 8 · standard — Label ↗AP
2015-10-29Manufacturing (CMC) · Supplement 3 · standardAP
2015-05-28Labeling · Supplement 5 · standard — Letter ↗AP
2015-01-02Manufacturing (CMC) · Supplement 1 · standardAP
2014-06-27Type 5 - New Formulation or New Manufacturer · 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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