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FDA ANDA · ANDA040728

BETHANECHOL CHLORIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA040728
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-26
LATEST ACTION
2019-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BETHANECHOL CHLORIDEPrescription
BETHANECHOL CHLORIDE 25MG · TABLET · ORAL
BETHANECHOL CHLORIDEPrescription
BETHANECHOL CHLORIDE 5MG · TABLET · ORAL
BETHANECHOL CHLORIDEPrescription
BETHANECHOL CHLORIDE 10MG · TABLET · ORAL
BETHANECHOL CHLORIDEPrescription
BETHANECHOL CHLORIDE 50MG · TABLET · ORAL

Approval history

2019-05-08Manufacturing (CMC) · Supplement 2 · unknownAP
2007-10-26OriginalAP
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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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