NDA 020105

PAR STERILE PRODUCTS

FDA Drug Application

Application #020105

Documents

• Letter: 2002-05-20
• Label: 2002-05-20

Application Sponsors

NDA 020105

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.01MG BASE/ML

1

TRIOSTAT

LIOTHYRONINE SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1991-12-31	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2002-05-20	STANDARD

Submissions Property Types

ORIG

1

Null

11

TE Codes

001

Prescription

AP

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20105
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIOSTAT","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.01MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/20\/2002","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20105s2lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRIOSTAT","submission":"LIOTHYRONINE SODIUM","actionType":"EQ 0.01MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2002-05-20
        )

)