APPLICATION
ANDA074815
TYPE
ANDA
ORIGINAL APPROVAL
1998-01-20
LATEST ACTION
2002-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ALPROSTADILPrescription
ALPROSTADIL 0.5MG/ML · INJECTABLE · INJECTION
Approval history
2002-09-11Manufacturing (CMC) · Supplement 5AP
2001-04-03Manufacturing (CMC) · Supplement 4AP
2000-07-11Labeling · Supplement 3AP
2000-07-11Manufacturing (CMC) · Supplement 1AP
2000-07-11Manufacturing (CMC) · Supplement 2AP
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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