APPLICATION
NDA016419
TYPE
NDA
ORIGINAL APPROVAL
1967-11-13
LATEST ACTION
2008-04-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROPRANOLOL HYDROCHLORIDE · ReferenceDiscontinued
PROPRANOLOL HYDROCHLORIDE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-02-06Labeling · Supplement 24 · standardAP
2001-12-07Manufacturing (CMC) · Supplement 25 · priorityAP
2001-02-14Manufacturing (CMC) · Supplement 23 · priorityAP
1999-08-22Labeling · Supplement 22 · standardAP
1997-11-07Labeling · Supplement 21 · standardAP
1990-02-14Labeling · Supplement 20AP
1988-12-06Manufacturing (CMC) · Supplement 19 · priorityAP
1988-08-12Manufacturing (CMC) · Supplement 18 · priorityAP
1985-06-18Manufacturing (CMC) · Supplement 17 · priorityAP
1982-06-23Manufacturing (CMC) · Supplement 16 · priorityAP
1982-06-23Manufacturing (CMC) · Supplement 15 · priorityAP
1981-03-12Manufacturing (CMC) · Supplement 14 · priorityAP
1979-01-17Labeling · Supplement 12AP
1978-12-12Labeling · Supplement 13AP
1978-08-21Labeling · Supplement 9AP
1967-11-13Type 3 - New Dosage Form · Original · 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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