ANDA 203048

AKORN INC

FDA Drug Application

Application #203048

Application Sponsors

ANDA 203048

AKORN INC

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	EQ 6MG BASE/ML	0	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE
002	INJECTABLE;INJECTION	EQ 12MG BASE/ML	0	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE
003	INJECTABLE;INJECTION	EQ 18MG BASE/ML	0	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-04-04
LABELING; Labeling	SUPPL	2	AP	2020-05-14	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-05-14	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-05-14	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-05-14	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	8	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203048
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 6MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 12MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 18MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/04\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/14\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/14\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/14\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/14\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/14\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-14
        )

)