NDA 020504

ALLERGAN

FDA Drug Application

Application #020504

Documents

• Letter: 2011-03-21
• Label: 2011-03-21
• Label: 2020-08-20
• Letter: 2020-08-21

Application Sponsors

NDA 020504

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

12.5MG

1

MICROZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-12-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-12-20	STANDARD
LABELING; Labeling	SUPPL	18	AP	2011-03-15	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2015-09-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2017-01-26	STANDARD
LABELING; Labeling	SUPPL	26	AP	2020-08-20	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	0
SUPPL	18	Null	6
SUPPL	23	Null	0
SUPPL	26	Null	6

TE Codes

001

Prescription

AB

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20504
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"MICROZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"12.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/15\/2011","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020504s018lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MICROZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"12.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-03-15
        )

)