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FDA NDA · NDA020755

CAVERJECT

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APPLICATION
NDA020755
TYPE
NDA
ORIGINAL APPROVAL
1997-10-31
LATEST ACTION
2003-09-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CAVERJECTDiscontinued
ALPROSTADIL 0.01MG/ML · INJECTABLE · INJECTION
CAVERJECTDiscontinued
ALPROSTADIL 0.02MG/ML · INJECTABLE · INJECTION
CAVERJECTDiscontinued
ALPROSTADIL 0.005MG/ML · INJECTABLE · INJECTION

Approval history

2003-09-02Labeling · Supplement 5 · standard — Letter ↗AP
2001-12-20Labeling · Supplement 4 · standardAP
1997-10-31Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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