ANDA 064136

PERRIGO CO

FDA Drug Application

Application #064136

Application Sponsors

ANDA 064136

PERRIGO CO

Marketing Status

• Prescription: 001

Application Products

001

SWAB;TOPICAL

EQ 1% BASE

0

CLINDETS

CLINDAMYCIN PHOSPHATE

FDA Submissions

	ORIG	1	AP	1996-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-10-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-10-17
LABELING; Labeling	SUPPL	5	AP	2002-11-01
LABELING; Labeling	SUPPL	8	AP	2003-12-09

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

TE Codes

001

Prescription

AT

CDER Filings

PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64136
            [companyName] => PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDETS","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 1% BASE","dosageForm":"SWAB;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLINDETS","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 1% BASE","submissionClassification":"SWAB;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)