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Approved Drug Products containing Norelgestromin listed in the FDA Orange Book. Original Data : FDA Website

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01 1AMNEAL

02 1JANSSEN PHARMS

03 1MYLAN TECHNOLOGIES

04 1TEVA PHARMS USA

05 1ZYDUS NOVELTECH INC

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PharmaCompass

01

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ETHINYL ESTRADIOL; NORELGESTROMIN

Brand Name : ETHINYL ESTRADIOL AND NORELGESTROMIN

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 0.035MG/24HR;0.15MG/24HR

Approval Date : 2021-02-25

Application Number : 213950

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ETHINYL ESTRADIOL; NORELGESTROMIN

Brand Name : ORTHO EVRA

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2001-11-20

Application Number : 21180

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ETHINYL ESTRADIOL; NORELGESTROMIN

Brand Name : ONSURA

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 0.035MG/24HR;0.15MG/24HR

Approval Date : 2021-08-25

Application Number : 213977

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ETHINYL ESTRADIOL; NORELGESTROMIN

Brand Name : XULANE

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 0.035MG/24HR;0.15MG/24HR

Approval Date : 2014-04-16

Application Number : 200910

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ETHINYL ESTRADIOL; NORELGESTROMIN

Brand Name : ETHINYL ESTRADIOL AND NORELGESTROMIN

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 0.035MG/24HR;0.15MG/24HR

Approval Date : 2023-09-14

Application Number : 214594

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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