NDA 215813

MERIDIAN LABORATORIES INC

FDA Drug Application

Application #215813

Documents

• Label: 2022-11-23
• Letter: 2022-11-25

Application Sponsors

NDA 215813

MERIDIAN LABORATORIES INC

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	10MG/ML	0	DOCETAXEL	DOCETAXEL
002	INJECTABLE;INJECTION	20MG/2ML	0	DOCETAXEL	DOCETAXEL
003	INJECTABLE;INJECTION	80MG/8ML	0	DOCETAXEL	DOCETAXEL
004	INJECTABLE;INJECTION	160MG/16ML	0	DOCETAXEL	DOCETAXEL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-11-22

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

MERIDIAN LABORATORIES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215813
            [companyName] => MERIDIAN LABORATORIES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"20MG\/2ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"80MG\/8ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"160MG\/16ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/22\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215813s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215813s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215813Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-11-22
        )

)