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FDA NDA · NDA019976

PHOSLO

Sponsor: FRESENIUS MEDCL CARE

APPLICATION
NDA019976
TYPE
NDA
ORIGINAL APPROVAL
1990-12-10
LATEST ACTION
2016-03-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PHOSLO · ReferenceDiscontinued
CALCIUM ACETATE 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2016-03-09Manufacturing (CMC) · Supplement 16 · priorityAP
2004-02-02Labeling · Supplement 6 · standard — Letter ↗AP
2002-11-04Labeling · Supplement 5 · standard — Letter ↗AP
1996-05-07Manufacturing (CMC) · Supplement 4 · priorityAP
1995-09-13Manufacturing (CMC) · Supplement 3 · priorityAP
1993-02-22Manufacturing (CMC) · Supplement 1 · priorityAP
1992-07-27Labeling · Supplement 2AP
1990-12-10Type 3 - New Dosage Form · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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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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