APPLICATION
ANDA076468
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-18
LATEST ACTION
2016-02-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ANAGRELIDE HYDROCHLORIDEPrescription
ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE · CAPSULE · ORAL
ANAGRELIDE HYDROCHLORIDEPrescription
ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE · CAPSULE · ORAL
Approval history
2016-02-29Labeling · Supplement 16 · standardAP
2015-06-02Labeling · Supplement 12 · standardAP
2015-06-02Labeling · Supplement 14 · standardAP
2013-03-20Labeling · Supplement 6AP
2012-09-13Labeling · Supplement 9AP
2012-08-24Labeling · Supplement 10AP
2010-08-31Labeling · Supplement 8AP
2010-08-31Labeling · Supplement 7AP
2008-10-23Labeling · Supplement 4AP
2008-08-28Labeling · Supplement 3AP
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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