← FDA DRUG APPROVALS

FDA NDA · NDA006927

EURAX

crotamiton

Sponsor: JOURNEY

APPLICATION
NDA006927
TYPE
NDA
ORIGINAL APPROVAL
1949-07-06
LATEST ACTION
2013-10-30
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

EURAX · ReferencePrescription
CROTAMITON 10% · CREAM · TOPICAL

Approval history

2013-10-30Manufacturing (CMC) · Supplement 33AP
2003-06-26Labeling · Supplement 30 — Letter ↗AP
2002-05-23Manufacturing (CMC) · Supplement 29AP
1989-08-25Manufacturing (CMC) · Supplement 27AP
1987-03-13Manufacturing (CMC) · Supplement 28AP
1984-11-26Manufacturing (CMC) · Supplement 26AP
1984-06-12Manufacturing (CMC) · Supplement 25AP
1984-05-08Manufacturing (CMC) · Supplement 24AP
1984-03-06Manufacturing (CMC) · Supplement 23AP
1983-09-09Labeling · Supplement 17AP
1983-02-04Manufacturing (CMC) · Supplement 22AP
1982-06-30Manufacturing (CMC) · Supplement 21 — Letter ↗AP
1982-05-28Manufacturing (CMC) · Supplement 20AP
1981-06-04Labeling · Supplement 19AP
1980-01-10Labeling · Supplement 15AP
1979-03-12Manufacturing (CMC) · Supplement 16AP
1978-10-05Labeling · Supplement 14AP
1977-10-27Manufacturing (CMC) · Supplement 10AP
1977-10-27Manufacturing (CMC) · Supplement 13AP
1977-10-27Manufacturing (CMC) · Supplement 11AP
1977-10-27Manufacturing (CMC) · Supplement 9AP
1977-10-27Manufacturing (CMC) · Supplement 12AP
1975-11-13Labeling · Supplement 8AP
1975-11-13Manufacturing (CMC) · Supplement 7AP
1949-07-06UNKNOWN · Original · unknownAP
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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