FDA NDA · NDA019038

CALAN

Sponsor: GD SEARLE LLC

APPLICATION

NDA019038

TYPE

NDA

ORIGINAL APPROVAL

1984-03-30

LATEST ACTION

2016-08-24

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

CALANDiscontinued

VERAPAMIL HYDROCHLORIDE 2.5MG/ML · INJECTABLE · INJECTION

2016-08-24Labeling · Supplement 5 · standard — Letter ↗AP

2011-11-02Labeling · Supplement 4 · unknown — Label ↗AP

2010-04-13Labeling · Supplement 3 · unknown — Letter ↗AP

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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