ANDA 204393

PIRAMAL CRITICAL

FDA Drug Application

Application #204393

Documents

• Letter: 2018-08-20

Application Sponsors

ANDA 204393

PIRAMAL CRITICAL

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	10MG/ML	0	MITIGO	MORPHINE SULFATE
002	INJECTABLE;INJECTION	25MG/ML	0	MITIGO	MORPHINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-07-16

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

PIRAMAL CRITICAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204393
            [companyName] => PIRAMAL CRITICAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MITIGO","activeIngredients":"MORPHINE SULFATE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MITIGO","activeIngredients":"MORPHINE SULFATE","strength":"25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204393Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/06\/2021","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-05-06
        )

)