ANDA 207757

ZYDUS PHARMS

FDA Drug Application

Application #207757

Application Sponsors

ANDA 207757

ZYDUS PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL	0	DOXYCYCLINE	DOXYCYCLINE HYCLATE
002	INJECTABLE;INJECTION	EQ 200MG BASE/VIAL	0	DOXYCYCLINE	DOXYCYCLINE HYCLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-09-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207757
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 100MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE HYCLATE","strength":"EQ 200MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/08\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-08
        )

)