ANDA 209655

ZYDUS NOVELTECH INC

FDA Drug Application

Application #209655

Application Sponsors

ANDA 209655

ZYDUS NOVELTECH INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007
• Prescription: 008

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	12.5MCG/HR	0	FENTANYL-12	FENTANYL
002	FILM, EXTENDED RELEASE;TRANSDERMAL	25MCG/HR	0	FENTANYL-25	FENTANYL
003	FILM, EXTENDED RELEASE;TRANSDERMAL	37.5MCG/HR	0	FENTANYL-37	FENTANYL
004	FILM, EXTENDED RELEASE;TRANSDERMAL	50MCG/HR	0	FENTANYL-50	FENTANYL
005	FILM, EXTENDED RELEASE;TRANSDERMAL	62.5MCG/HR	0	FENTANYL-62	FENTANYL
006	FILM, EXTENDED RELEASE;TRANSDERMAL	75MCG/HR	0	FENTANYL-75	FENTANYL
007	FILM, EXTENDED RELEASE;TRANSDERMAL	87.5MCG/HR	0	FENTANYL-87	FENTANYL
008	FILM, EXTENDED RELEASE;TRANSDERMAL	100MCG/HR	0	FENTANYL-100	FENTANYL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB
007	Prescription	AB
008	Prescription	AB

CDER Filings

ZYDUS NOVELTECH INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209655
            [companyName] => ZYDUS NOVELTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENTANYL-100","activeIngredients":"FENTANYL","strength":"100MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-12","activeIngredients":"FENTANYL","strength":"12.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-25","activeIngredients":"FENTANYL","strength":"25MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-37","activeIngredients":"FENTANYL","strength":"37.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-50","activeIngredients":"FENTANYL","strength":"50MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-62","activeIngredients":"FENTANYL","strength":"62.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-75","activeIngredients":"FENTANYL","strength":"75MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENTANYL-87","activeIngredients":"FENTANYL","strength":"87.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/24\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-24
        )

)