NDA 050782

BAUSCH

FDA Drug Application

Application #050782

Documents

• Review: 2004-07-15
• Letter: 2000-11-27
• Label: 2003-05-02

Application Sponsors

NDA 050782

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

EQ 1% BASE

1

CLINDAGEL

CLINDAMYCIN PHOSPHATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2000-11-27

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

BT

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50782
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAGEL","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 1% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/27\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50782lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLINDAGEL","submission":"CLINDAMYCIN PHOSPHATE","actionType":"EQ 1% BASE","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2000-11-27
        )

)