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FDA Drug information

Norelgestromin and ethinyl estradiol

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20230916

Version

1

Spl Product Data Elements

norelgestromin and ethinyl estradiol norelgestromin and ethinyl estradiol NORELGESTROMIN NORELGESTROMIN ETHINYL ESTRADIOL ETHINYL ESTRADIOL CROSPOVIDONE LAURYL LACTATE

Application Number

ANDA214594

Brand Name

Norelgestromin and ethinyl estradiol

Generic Name

norelgestromin and ethinyl estradiol

Product Ndc

70771-1777

Product Type

HUMAN PRESCRIPTION DRUG

Route

TRANSDERMAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1777-3 Norelgestromin and Ethinyl Estradiol Transdermal System 150/35 mcg per day This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. For Transdermal Use Only Contents: 3 Transdermal Systems Rx only Each 15.75 cm 2 system contains 4.678 mg norelgestromin, USP and 0.53 mg ethinyl estradiol, USP. The inactive components are polyisobutylene/polybutene adhesive, crospovidone, lauryl lactate, non-woven polyester fabric, polyester backing film laminate and polyester release liner. See patient instructions. Apply immediately upon removal from pouch. Each transdermal system is intended to be worn 7 days as prescribed. Package not child-resistant. Keep out of reach of children. Do not store unpouched. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 10/22 carton

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