ANDA 209393

NOSTRUM LABS INC

FDA Drug Application

Application #209393

Application Sponsors

ANDA 209393

NOSTRUM LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	EQ 50MG BASE	0	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE
002	CAPSULE;ORAL	EQ 100MG BASE	0	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-12-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209393
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE HYCLATE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-10
        )

)