APPLICATION
ANDA078022
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-15
LATEST ACTION
2024-08-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 160MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-08-23Labeling · Supplement 8 · standardAP
2015-06-13Labeling · Supplement 5 · standardAP
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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