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FDA NDA · NDA010515

ISUPREL

Sponsor: BAUSCH

APPLICATION
NDA010515
TYPE
NDA
ORIGINAL APPROVAL
1956-05-25
LATEST ACTION
2022-10-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ISUPREL · ReferenceDiscontinued
ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2022-10-20Labeling · Supplement 33 · standard — Letter ↗AP
2013-03-21Manufacturing (CMC) · Supplement 31 · priority — Review ↗AP
2001-07-18Manufacturing (CMC) · Supplement 24 · priority — Review ↗AP
2000-02-23Labeling · Supplement 23 · standard — Review ↗AP
1999-05-04Efficacy · Supplement 22 · standard — Review ↗AP
1996-02-14Labeling · Supplement 19AP
1996-02-14Labeling · Supplement 21 · standardAP
1992-03-09Manufacturing (CMC) · Supplement 20 · priorityAP
1989-02-06Labeling · Supplement 18AP
1987-12-08Labeling · Supplement 16AP
1987-07-24Labeling · Supplement 17AP
1986-10-08Labeling · Supplement 14AP
1986-10-08Efficacy · Supplement 7AP
1984-09-26Manufacturing (CMC) · Supplement 15 · priorityAP
1979-09-05Labeling · Supplement 11AP
1978-08-11Manufacturing (CMC) · Supplement 13 · priorityAP
1978-08-04Manufacturing (CMC) · Supplement 12 · priorityAP
1974-02-06Labeling · Supplement 6AP
1956-05-25Type 3 - New Dosage Form · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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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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