NDA 215000

ACCORD HLTHCARE INC

FDA Drug Application

Application #215000

Documents

• Letter: 2022-05-17
• Label: 2022-05-17
• Review: 2022-11-10

Application Sponsors

NDA 215000

ACCORD HLTHCARE INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	50MG/VIAL	0	CARMUSTINE	CARMUSTINE
002	POWDER;INTRAVENOUS	300MG/VIAL	1	CARMUSTINE	CARMUSTINE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

AP

2022-05-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ACCORD HLTHCARE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215000
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARMUSTINE","activeIngredients":"CARMUSTINE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/16\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215000s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/16\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215000s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215000Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-05-16
        )

)