ANDA 203649

SANDOZ INC

FDA Drug Application

Application #203649

Documents

• Letter: 2014-11-04
• Label: 2017-12-04

Application Sponsors

ANDA 203649

SANDOZ INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	1MG/ML	0	TREPROSTINIL	TREPROSTINIL
002	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	2.5MG/ML	0	TREPROSTINIL	TREPROSTINIL
003	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	5MG/ML	0	TREPROSTINIL	TREPROSTINIL
004	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	10MG/ML	0	TREPROSTINIL	TREPROSTINIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-11-30
LABELING; Labeling	SUPPL	2	AP	2018-11-20	STANDARD
LABELING; Labeling	SUPPL	4	AP	2018-11-20	STANDARD
LABELING; Labeling	SUPPL	5	AP	2018-11-20	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203649
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"1MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"2.5MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"5MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TREPROSTINIL","activeIngredients":"TREPROSTINIL","strength":"10MG\/ML","dosageForm":"INJECTABLE;IV (INFUSION), SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/30\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203649Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/30\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203649Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203649Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/20\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/20\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/20\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/18\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-11-20
        )

)