ANDA 206241

ZYDUS NOVELTECH INC

FDA Drug Application

Application #206241

Application Sponsors

ANDA 206241

ZYDUS NOVELTECH INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	SYSTEM;TRANSDERMAL	0.025MG/24HR	0	ESTRADIOL	ESTRADIOL
002	SYSTEM;TRANSDERMAL	0.0375MG/24HR	0	ESTRADIOL	ESTRADIOL
003	SYSTEM;TRANSDERMAL	0.05MG/24HR	0	ESTRADIOL	ESTRADIOL
004	SYSTEM;TRANSDERMAL	0.075MG/24HR	0	ESTRADIOL	ESTRADIOL
005	SYSTEM;TRANSDERMAL	0.1MG/24HR	0	ESTRADIOL	ESTRADIOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1
004	Prescription	AB1
005	Prescription	AB1

CDER Filings

ZYDUS NOVELTECH INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206241
            [companyName] => ZYDUS NOVELTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.025MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.0375MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.05MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.075MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.1MG\/24HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.025MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.0375MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.05MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.075MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL","submission":"ESTRADIOL","actionType":"0.1MG\/24HR","submissionClassification":"SYSTEM;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)