APPLICATION
ANDA202220
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-19
LATEST ACTION
2026-01-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PROTRIPTYLINE HYDROCHLORIDEPrescription
PROTRIPTYLINE HYDROCHLORIDE 10MG · TABLET · ORAL
PROTRIPTYLINE HYDROCHLORIDEPrescription
PROTRIPTYLINE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-01-07Labeling · Supplement 4 · standardAP
2020-08-11Manufacturing (CMC) · Supplement 3AP
2014-07-17Labeling · Supplement 1 · standardAP
2012-11-19OriginalAP
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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