ANDA 207402

MICRO LABS

FDA Drug Application

Application #207402

Application Sponsors

ANDA 207402

MICRO LABS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	EQ 75MG BASE	0	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 150MG BASE	0	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 300MG BASE	0	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-11-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MICRO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207402
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLINDAMYCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLINDAMYCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 300MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-05
        )

)