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FDA ANDA · ANDA077132

RISEDRONATE SODIUM

Sponsor: TEVA PHARMS USA

APPLICATION
ANDA077132
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-05
LATEST ACTION
2026-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

RISEDRONATE SODIUMPrescription
RISEDRONATE SODIUM 35MG · TABLET · ORAL
RISEDRONATE SODIUMPrescription
RISEDRONATE SODIUM 5MG · TABLET · ORAL
RISEDRONATE SODIUMPrescription
RISEDRONATE SODIUM 30MG · TABLET · ORAL

Approval history

2026-06-08Labeling · Supplement 13 · standardAP
2023-03-15Labeling · Supplement 11 · standardAP
2020-08-14Labeling · Supplement 9 · standardAP
2015-11-16Labeling · Supplement 6 · standardAP
2015-11-16Labeling · Supplement 3AP
2014-11-05Labeling · Supplement 4 · standardAP
2007-10-05Original — 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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