ANDA 076470

ACTAVIS LABS FL INC

FDA Drug Application

Application #076470

Documents

• Letter: 2005-07-08

Application Sponsors

ANDA 076470

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	0.1MG	0	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE
002	TABLET;ORAL	0.2MG	0	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE

FDA Submissions

	ORIG	1	AP	2005-07-01
LABELING; Labeling	SUPPL	6	AP	2008-02-23
LABELING; Labeling	SUPPL	21	AP	2015-12-02	STANDARD

Submissions Property Types

SUPPL

21

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76470
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESMOPRESSIN ACETATE","activeIngredients":"DESMOPRESSIN ACETATE","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DESMOPRESSIN ACETATE","activeIngredients":"DESMOPRESSIN ACETATE","strength":"0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DESMOPRESSIN ACETATE","submission":"DESMOPRESSIN ACETATE","actionType":"0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DESMOPRESSIN ACETATE","submission":"DESMOPRESSIN ACETATE","actionType":"0.2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)