ANDA 088618

PLIVA

FDA Drug Application

Application #088618

Documents

• Label: 2014-04-18
• Label: 2014-06-24
• Letter: 2014-06-11

Application Sponsors

ANDA 088618

PLIVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG

0

HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1986-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-08-01
LABELING; Labeling	SUPPL	5	AP	1991-01-14
LABELING; Labeling	SUPPL	6	AP	1994-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-07-07
LABELING; Labeling	SUPPL	12	AP	2002-01-30
LABELING; Labeling	SUPPL	18	AP	2004-02-04
LABELING; Labeling	SUPPL	28	AP	2008-08-05
LABELING; Labeling	SUPPL	43	AP	2014-06-05	STANDARD
LABELING; Labeling	SUPPL	44	AP	2016-03-29	STANDARD
LABELING; Labeling	SUPPL	45	AP	2016-03-30	STANDARD
LABELING; Labeling	SUPPL	47	AP	2016-11-08	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	43	Null	7
SUPPL	44	Null	7
SUPPL	45	Null	15
SUPPL	47	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88618
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYZINE HYDROCHLORIDE","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/05\/2014","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/088617Orig1s043,088618Orig1s043,088619Orig1s044lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2008","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/088617s030,088618s028,088619s031lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HYDROXYZINE HYDROCHLORIDE","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2014-06-05
        )

)