APPLICATION
ANDA070665
TYPE
ANDA
ORIGINAL APPROVAL
1986-06-13
LATEST ACTION
2001-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROPRANOLOL HYDROCHLORIDEDiscontinued
PROPRANOLOL HYDROCHLORIDE 40MG · TABLET · ORAL
Approval history
2001-05-09Manufacturing (CMC) · Supplement 15AP
1995-05-18Manufacturing (CMC) · Supplement 14AP
1992-05-22Labeling · Supplement 13AP
1989-07-10Labeling · Supplement 12AP
1988-12-23Manufacturing (CMC) · Supplement 9AP
1988-12-23Manufacturing (CMC) · Supplement 10AP
1988-12-23Labeling · Supplement 6AP
1988-12-23Manufacturing (CMC) · Supplement 4AP
1988-11-29Labeling · Supplement 11AP
1988-11-15Manufacturing (CMC) · Supplement 5AP
1988-02-11Manufacturing (CMC) · Supplement 8AP
1987-07-31Labeling · Supplement 7AP
1987-02-05Manufacturing (CMC) · Supplement 1AP
1986-12-18Labeling · Supplement 3AP
1986-12-15Labeling · Supplement 2AP
1986-06-13OriginalAP
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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