ANDA 206163

PIRAMAL CRITICAL

FDA Drug Application

Application #206163

Documents

• Letter: 2016-07-01
• Label: 2016-07-18

Application Sponsors

ANDA 206163

PIRAMAL CRITICAL

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;INTRAVENOUS	100MCG/VIAL	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM
002	POWDER;INTRAVENOUS	500MCG/VIAL	0	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-06-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

PIRAMAL CRITICAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206163
            [companyName] => PIRAMAL CRITICAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"100MCG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOTHYROXINE SODIUM","activeIngredients":"LEVOTHYROXINE SODIUM","strength":"500MCG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/29\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206163ORig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206163ORig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206163Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-06-29
        )

)