ANDA 205771

HIKMA PHARMS

FDA Drug Application

Application #205771

Documents

• Letter: 2016-03-04

Application Sponsors

ANDA 205771

HIKMA PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	ACYCLOVIR SODIUM	ACYCLOVIR SODIUM
002	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	ACYCLOVIR SODIUM	ACYCLOVIR SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-02-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205771
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR SODIUM","activeIngredients":"ACYCLOVIR SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ACYCLOVIR SODIUM","activeIngredients":"ACYCLOVIR SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205771Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-02-29
        )

)