ANDA 201692

SANDOZ INC

FDA Drug Application

Application #201692

Documents

• Review: 2012-10-09

Application Sponsors

ANDA 201692

SANDOZ 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

N/A; Not Applicable	ORIG	1	AP	2012-05-31
LABELING; Labeling	SUPPL	5	AP	2020-05-18	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-05-18	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-05-18	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-05-18	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-05-18	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-05-18	STANDARD
LABELING; Labeling	SUPPL	20	AP	2022-10-18	STANDARD
LABELING; Labeling	SUPPL	24	AP	2022-10-18	STANDARD
LABELING; Labeling	SUPPL	25	AP	2022-10-18	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	15
SUPPL	7	Null	31
SUPPL	8	Null	15
SUPPL	12	Null	15
SUPPL	16	Null	7
SUPPL	18	Null	7
SUPPL	20	Null	15
SUPPL	24	Null	7
SUPPL	25	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201692
            [companyName] => SANDOZ 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":"05\/31\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/201692Orig1s000Approv.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/18\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/18\/2020","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/18\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/18\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/18\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/18\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-18
        )

)