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FDA ANDA · ANDA076984

ALENDRONATE SODIUM

Sponsor: WATSON LABS

APPLICATION
ANDA076984
TYPE
ANDA
ORIGINAL APPROVAL
2008-08-04
LATEST ACTION
2016-03-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 40MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 70MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 35MG BASE · TABLET · ORAL

Approval history

2016-03-04Labeling · Supplement 14 · standardAP
2016-03-04Labeling · Supplement 10 · standardAP
2013-05-03Labeling · Supplement 8 · standardAP
2011-06-29Labeling · Supplement 7AP
2010-08-24Labeling · Supplement 4AP
2009-07-23Labeling · Supplement 2AP
2008-08-04Original — Other Important Information from FDA ↗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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