← FDA DRUG APPROVALS

FDA NDA · NDA022436

XERESE

acyclovir and hydrocortisone

Sponsor: BAUSCH

APPLICATION
NDA022436
TYPE
NDA
ORIGINAL APPROVAL
2009-07-31
LATEST ACTION
2019-12-11
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

XERESE · ReferencePrescription
ACYCLOVIR 5%, HYDROCORTISONE 1% · CREAM · TOPICAL

Approval history

2019-12-11Labeling · Supplement 10 · standard — Label ↗AP
2016-04-14Manufacturing (CMC) · Supplement 6 · standardAP
2015-11-24Manufacturing (CMC) · Supplement 5 · standardAP
2014-01-22Efficacy · Supplement 4 · priority — Pediatric Medical Review ↗AP
2010-05-12Labeling · Supplement 1 · unknown — Letter ↗AP
2009-07-31Type 4 - New Combination · Original · standard — Pediatric Medical Review ↗AP
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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