APPLICATION
ANDA203103
TYPE
ANDA
ORIGINAL APPROVAL
2026-05-01
LATEST ACTION
2026-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 160MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2026-05-01UNKNOWN · OriginalAP
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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