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FDA NDA · NDA020700

MUSE

Sponsor: VIATRIS

APPLICATION
NDA020700
TYPE
NDA
ORIGINAL APPROVAL
1996-11-19
LATEST ACTION
2024-05-17
ROUTE
URETHRAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued

Products

MUSE · ReferenceDiscontinued
ALPROSTADIL 0.5MG · SUPPOSITORY · URETHRAL
MUSE · ReferenceDiscontinued
ALPROSTADIL 0.125MG · SUPPOSITORY · URETHRAL
MUSE · ReferenceDiscontinued
ALPROSTADIL 1MG · SUPPOSITORY · URETHRAL
MUSE · ReferenceDiscontinued
ALPROSTADIL 0.25MG · SUPPOSITORY · URETHRAL

Approval history

2024-05-17Labeling · Supplement 32 · standard — Letter ↗AP
2002-07-30Manufacturing (CMC) · Supplement 12 · priorityAP
2002-06-04Manufacturing (CMC) · Supplement 11 · priorityAP
1998-06-24Manufacturing (CMC) · Supplement 10 · priorityAP
1998-03-31Manufacturing (CMC) · Supplement 8 · priorityAP
1998-03-30Labeling · Supplement 7 · standardAP
1998-01-27Manufacturing (CMC) · Supplement 3 · priorityAP
1997-09-09Manufacturing (CMC) · Supplement 5 · priorityAP
1997-09-09Manufacturing (CMC) · Supplement 6 · priorityAP
1997-09-09Manufacturing (CMC) · Supplement 4 · priorityAP
1997-05-13Manufacturing (CMC) · Supplement 2 · priorityAP
1997-02-13Manufacturing (CMC) · Supplement 1 · priorityAP
1996-11-19Type 3 - New Dosage Form · Original · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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