ANDA 211899

WAVERLEY PHARMA INTERNATIONAL INC

FDA Drug Application

Application #211899

Application Sponsors

ANDA 211899

WAVERLEY PHARMA INTERNATIONAL INC

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002

Application Products

001	POWDER;INTRAVENOUS	EQ 100MG BASE/VIAL	0	PEMETREXED DISODIUM	PEMETREXED DISODIUM
002	POWDER;INTRAVENOUS	EQ 500MG BASE/VIAL	0	PEMETREXED DISODIUM	PEMETREXED DISODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-11-02

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

WAVERLEY PHARMA INTERNATIONAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211899
            [companyName] => WAVERLEY PHARMA INTERNATIONAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/02\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-02
        )

)