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FDA ANDA · ANDA076768

ALENDRONATE SODIUM

Sponsor: CIPLA

APPLICATION
ANDA076768
TYPE
ANDA
ORIGINAL APPROVAL
2008-08-04
LATEST ACTION
2019-01-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 5MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 40MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 10MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 70MG BASE · TABLET · ORAL
ALENDRONATE SODIUMPrescription
ALENDRONATE SODIUM EQ 35MG BASE · TABLET · ORAL

Approval history

2019-01-15Labeling · Supplement 7 · standardAP
2016-02-12Labeling · Supplement 4 · standardAP
2016-02-12Labeling · Supplement 6 · standardAP
2011-07-07Labeling · 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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