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FDA NDA · NDA021823

ACTONEL WITH CALCIUM (COPACKAGED)

Sponsor: WARNER CHILCOTT

APPLICATION
NDA021823
TYPE
NDA
ORIGINAL APPROVAL
2005-08-12
LATEST ACTION
2015-04-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACTONEL WITH CALCIUM (COPACKAGED) · ReferenceDiscontinued
CALCIUM CARBONATE EQ 500MG BASE, RISEDRONATE SODIUM 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2015-04-08Labeling · Supplement 11 · standard — Medication Guide ↗AP
2015-03-26Labeling · Supplement 10 · standard — Letter ↗AP
2013-04-19Labeling · Supplement 9 · standard — Label ↗AP
2011-08-22REMS · Supplement 8 — Letter ↗AP
2011-01-25REMS · Supplement 6 — Letter ↗AP
2011-01-25Labeling · Supplement 7 · unknown — Label ↗AP
2006-08-22Labeling · Supplement 4 · standard — Label ↗AP
2006-06-19Labeling · Supplement 3 · standard — Letter ↗AP
2006-01-24Labeling · Supplement 2 · standard — Label ↗AP
2005-08-12Type 4 - New Combination · Original · standard — Label ↗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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