APPLICATION
NDA016418
TYPE
NDA
ORIGINAL APPROVAL
1967-11-13
LATEST ACTION
2011-03-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
INDERAL · ReferenceDiscontinued
PROPRANOLOL HYDROCHLORIDE 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
INDERAL · ReferenceDiscontinued
PROPRANOLOL HYDROCHLORIDE 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
INDERAL · ReferenceDiscontinued
PROPRANOLOL HYDROCHLORIDE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
INDERAL · ReferenceDiscontinued
PROPRANOLOL HYDROCHLORIDE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
INDERAL · ReferenceDiscontinued
PROPRANOLOL HYDROCHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
INDERAL · ReferenceDiscontinued
PROPRANOLOL HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-02-06Labeling · Supplement 72 · standardAP
1999-08-22Labeling · Supplement 71 · standardAP
1997-11-07Labeling · Supplement 70 · standardAP
1990-02-15Labeling · Supplement 69AP
1989-03-30Manufacturing (CMC) · Supplement 68 · priorityAP
1988-05-25Manufacturing (CMC) · Supplement 67 · priorityAP
1987-01-20Manufacturing (CMC) · Supplement 66 · priorityAP
1986-10-31Efficacy · Supplement 51AP
1986-10-31Efficacy · Supplement 35AP
1986-10-31Efficacy · Supplement 44AP
1985-10-09Manufacturing (CMC) · Supplement 64 · priorityAP
1985-06-18Manufacturing (CMC) · Supplement 55 · priorityAP
1985-02-28Manufacturing (CMC) · Supplement 63 · priorityAP
1985-02-25Manufacturing (CMC) · Supplement 61 · priorityAP
1985-02-22Manufacturing (CMC) · Supplement 57 · priorityAP
1984-12-20Manufacturing (CMC) · Supplement 62 · priorityAP
1984-05-21Manufacturing (CMC) · Supplement 58 · priorityAP
1984-01-12Manufacturing (CMC) · Supplement 56 · priorityAP
1983-09-30Efficacy · Supplement 47AP
1983-03-21Manufacturing (CMC) · Supplement 41 · priorityAP
1983-01-21Labeling · Supplement 54AP
1983-01-07Manufacturing (CMC) · Supplement 53 · priorityAP
1982-11-12Manufacturing (CMC) · Supplement 52 · priorityAP
1982-10-18Labeling · Supplement 49AP
1982-10-18Efficacy · Supplement 48AP
1982-02-08Manufacturing (CMC) · Supplement 46 · priorityAP
1982-01-26Labeling · Supplement 43AP
1981-10-15Manufacturing (CMC) · Supplement 45 · priorityAP
1980-09-19Manufacturing (CMC) · Supplement 39 · priorityAP
1980-09-16Manufacturing (CMC) · Supplement 38 · priorityAP
1980-03-24Manufacturing (CMC) · Supplement 37 · priorityAP
1980-03-24Manufacturing (CMC) · Supplement 36 · priorityAP
1979-05-03Manufacturing (CMC) · Supplement 32 · priorityAP
1979-03-21Manufacturing (CMC) · Supplement 33 · priorityAP
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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