FDA ANDA · ANDA212491
CYPROHEPTADINE HYDROCHLORIDE
Sponsor: QUAGEN
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APPLICATION
ANDA212491
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-24
LATEST ACTION
2026-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CYPROHEPTADINE HYDROCHLORIDEPrescription
CYPROHEPTADINE HYDROCHLORIDE 4MG · TABLET · ORAL
CYPROLARAPrescription
CYPROHEPTADINE HYDROCHLORIDE 2MG · TABLET · ORAL
Approval history
2026-10-02Manufacturing (CMC) · Supplement 3 · unknownAP
2021-02-24UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →