← FDA DRUG APPROVALS

FDA NDA · NDA021302

PIMECROLIMUS

Sponsor: BAUSCH

APPLICATION
NDA021302
TYPE
NDA
ORIGINAL APPROVAL
2001-12-13
LATEST ACTION
2016-06-09
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

ELIDEL · ReferencePrescription
PIMECROLIMUS 1% · CREAM · TOPICAL

Approval history

2016-06-09Manufacturing (CMC) · Supplement 23 · standardAP
2014-09-26Manufacturing (CMC) · Supplement 20 · standardAP
2014-08-21Manufacturing (CMC) · Supplement 21 · standardAP
2014-06-04Manufacturing (CMC) · Supplement 19 · standardAP
2014-03-28Labeling · Supplement 18 · standard — Letter ↗AP
2010-07-20Labeling · Supplement 14 · standard — Letter ↗AP
2007-09-14Manufacturing (CMC) · Supplement 13AP
2007-08-10Labeling · Supplement 12 · standard — Letter ↗AP
2006-01-19Labeling · Supplement 11 · standard — Label ↗AP
2004-11-24Labeling · Supplement 5 · standard — Label ↗AP
2003-10-15Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2002-11-15Manufacturing (CMC) · Supplement 1 · standardAP
2001-12-13Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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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