ANDA 074738

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #074738

Application Sponsors

ANDA 074738

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

200MG/5ML

0

ACYCLOVIR

ACYCLOVIR

FDA Submissions

	ORIG	1	AP	1997-04-28
LABELING; Labeling	SUPPL	2	AP	1998-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-01-16
LABELING; Labeling	SUPPL	4	AP	2000-11-16
LABELING; Labeling	SUPPL	5	AP	2001-06-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-02-22
LABELING; Labeling	SUPPL	7	AP	2002-09-18
LABELING; Labeling	SUPPL	12	AP	2005-01-24
LABELING; Labeling	SUPPL	28	AP	2009-06-10

Submissions Property Types

SUPPL	3	Null	0
SUPPL	6	Null	0

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74738
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"200MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACYCLOVIR","submission":"ACYCLOVIR","actionType":"200MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)