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FDA NDA · NDA202408

AVACLYR

acyclovir

Sponsor: FERA PHARMS LLC

APPLICATION
NDA202408
TYPE
NDA
ORIGINAL APPROVAL
2019-03-29
LATEST ACTION
2021-07-16
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

AVACLYR · ReferenceDiscontinued
ACYCLOVIR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · OPHTHALMIC

Approval history

2021-07-16Labeling · Supplement 1 · standard — Letter ↗AP
2019-03-29Type 3 - New Dosage Form · Original · standard — Label ↗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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