NDA 202408

FERA PHARMS LLC

FDA Drug Application

Application #202408

Documents

• Label: 2019-04-02
• Letter: 2019-04-04
• Review: 2019-07-12
• Letter: 2021-07-19
• Label: 2021-07-20

Application Sponsors

NDA 202408

FERA PHARMS LLC

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;OPHTHALMIC

3%

1

AVACLYR

ACYCLOVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2019-03-29

STANDARD

Submissions Property Types

ORIG

1

Orphan

5

CDER Filings

FERA PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202408
            [companyName] => FERA PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AVACLYR","activeIngredients":"ACYCLOVIR","strength":"3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/16\/2021","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/202408s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/0202408s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/29\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/0202408s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/202408Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/202408Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/16\/2021","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/202408s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/202408Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-07-16
        )

)