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FDA ANDA · ANDA216736

DICYCLOMINE HYDROCHLORIDE

Sponsor: RUBICON RESEARCH

APPLICATION
ANDA216736
TYPE
ANDA
ORIGINAL APPROVAL
2022-12-14
LATEST ACTION
2025-09-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DICYCLOMINE HYDROCHLORIDEPrescription
DICYCLOMINE HYDROCHLORIDE 20MG · TABLET · ORAL
DICYCLOMINE HYDROCHLORIDEPrescription
DICYCLOMINE HYDROCHLORIDE 40MG · TABLET · ORAL

Approval history

2025-09-15Manufacturing (CMC) · Supplement 3 · unknownAP
2022-12-14UNKNOWN · Original · standardAP
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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