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FDA Drug information

Estradiol

Read time: 1 mins
Marketing start date: 28 Dec 2024
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Summary of product characteristics


Effective Time

20230421

Version

1

Spl Product Data Elements

estradiol estradiol ESTRADIOL ESTRADIOL SILICON DIOXIDE ETHYL OLEATE ISOPROPYL MYRISTATE GLYCERYL LAURATE POVIDONE 2-ETHYLHEXYL ACRYLATE 2-HYDROXYETHYL ACRYLATE GLYCIDYL METHACRYLATE

Application Number

ANDA204379

Brand Name

Estradiol

Generic Name

estradiol

Product Ndc

70771-1400

Product Type

HUMAN PRESCRIPTION DRUG

Route

TRANSDERMAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771- 1400 -4 Estradiol Transdermal System, USP 0.014 mg/day Apply one transdermal system per week. For Transdermal Use Only Contents: 4 Transdermal Systems Rx Only zydus Pharmaceuticals USA Estradiol Transdermal System USP 0.014 mg

Spl Unclassified Section

SPL UNCLASSIFIED

Drug section

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