ANDA 211935

ALEMBIC PHARMS LTD

FDA Drug Application

Application #211935

Application Sponsors

ANDA 211935

ALEMBIC PHARMS LTD

Marketing Status

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

Application Products

001	CAPSULE;ORAL	25MG	0	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE
002	CAPSULE;ORAL	50MG	0	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE
003	CAPSULE;ORAL	100MG	0	NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-06-25

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211935
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITROFURANTOIN","activeIngredients":"NITROFURANTOIN, MACROCRYSTALLINE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-25
        )

)