ANDA 065095

HIKMA INTL PHARMS

FDA Drug Application

Application #065095

Documents

• Letter: 2014-07-24
• Label: 2014-07-30

Application Sponsors

ANDA 065095

HIKMA INTL PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 100MG BASE

0

DOXYCYCLINE HYCLATE

DOXYCYCLINE HYCLATE

FDA Submissions

	ORIG	1	AP	2003-07-02
LABELING; Labeling	SUPPL	10	AP	2009-05-12
LABELING; Labeling	SUPPL	11	AP	2011-11-30
LABELING; Labeling	SUPPL	14	AP	2014-06-25	STANDARD

Submissions Property Types

SUPPL	11	Null	15
SUPPL	14	Null	15

TE Codes

001

Prescription

AB

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65095
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/25\/2014","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/065095Orig1s014lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DOXYCYCLINE HYCLATE","submission":"DOXYCYCLINE HYCLATE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2014-06-25
        )

)