APPLICATION
ANDA090321
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-25
LATEST ACTION
2011-03-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 160MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPRANOLOL HYDROCHLORIDEPrescription
PROPRANOLOL HYDROCHLORIDE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2011-03-25OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.