ANDA 077149

PERRIGO ISRAEL

FDA Drug Application

Application #077149

Documents

• Letter: 2006-04-05

Application Sponsors

ANDA 077149

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

SUPPOSITORY;VAGINAL

80MG

0

TERCONAZOLE

TERCONAZOLE

FDA Submissions

	ORIG	1	AP	2006-03-17
LABELING; Labeling	SUPPL	4	AP	2016-02-20	STANDARD

Submissions Property Types

SUPPL

4

Null

15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77149
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERCONAZOLE","activeIngredients":"TERCONAZOLE","strength":"80MG","dosageForm":"SUPPOSITORY;VAGINAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TERCONAZOLE","submission":"TERCONAZOLE","actionType":"80MG","submissionClassification":"SUPPOSITORY;VAGINAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)