APPLICATION
ANDA078213
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-10
LATEST ACTION
2015-06-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 60MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 20MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 80MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 40MG · TABLET · ORAL
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2015-06-11Labeling · Supplement 9 · standardAP
2015-06-11Labeling · Supplement 8 · standardAP
2012-01-27Labeling · Supplement 6AP
2011-11-01Labeling · Supplement 3AP
2008-12-15Labeling · Supplement 1AP
2008-01-10OriginalAP
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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