FDA NDA · NDA018925

VERAPAMIL HYDROCHLORIDE

Sponsor: EXELA PHARMA

APPLICATION

NDA018925

TYPE

NDA

ORIGINAL APPROVAL

1984-03-30

LATEST ACTION

2016-11-18

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued, Prescription

Products

VERAPAMIL HYDROCHLORIDEDiscontinued

VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) · SOLUTION · INTRAVENOUS

VERAPAMIL HYDROCHLORIDEPrescription

VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) · SOLUTION · INTRAVENOUS

2016-11-18Labeling · Supplement 10 · standard — Letter ↗AP

2016-04-08Manufacturing (CMC) · Supplement 9AP

2011-11-02Labeling · Supplement 8 · unknown — Letter ↗AP

2010-04-13Labeling · Supplement 7 · unknown — Letter ↗AP

1988-10-25Labeling · Supplement 6AP

1986-09-16Manufacturing (CMC) · Supplement 4 · standardAP

1986-09-15Labeling · Supplement 5AP

1986-09-15Labeling · Supplement 3AP

1985-02-21Manufacturing (CMC) · Supplement 2 · standardAP

1984-07-10Manufacturing (CMC) · Supplement 1 · standardAP

1984-03-30Type 5 - New Formulation or New Manufacturer · Original · standardAP

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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