← FDA DRUG APPROVALS

FDA NDA · NDA021160

PHOSLO GELCAPS

Sponsor: FRESENIUS MEDCL CARE

APPLICATION
NDA021160
TYPE
NDA
ORIGINAL APPROVAL
2001-04-02
LATEST ACTION
2016-06-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PHOSLO GELCAPS · ReferenceDiscontinued
CALCIUM ACETATE 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
PHOSLODiscontinued
CALCIUM ACETATE 333.5MG · CAPSULE · ORAL
PHOSLODiscontinued
CALCIUM ACETATE 667MG · CAPSULE · ORAL

Approval history

2016-06-22Manufacturing (CMC) · Supplement 32 · standardAP
2016-04-12Manufacturing (CMC) · Supplement 29 · standardAP
2016-03-24Manufacturing (CMC) · Supplement 31 · standardAP
2015-04-29Manufacturing (CMC) · Supplement 27 · standardAP
2014-05-27Manufacturing (CMC) · Supplement 28 · standardAP
2013-09-12Manufacturing (CMC) · Supplement 26 · standardAP
2013-02-21Manufacturing (CMC) · Supplement 25 · standardAP
2011-03-29Labeling · Supplement 15 · unknown — Label ↗AP
2004-02-02Labeling · Supplement 1 · standard — Letter ↗AP
2001-04-02Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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