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

Application Number

ANDA202985

Brand Name

Estradiol

Generic Name

estradiol

Product Ndc

70771-1403

Product Type

HUMAN PRESCRIPTION DRUG

Route

TRANSDERMAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771- 1401 -4 Estradiol Transdermal System, USP 0.025 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1402 -4 Estradiol Transdermal System, USP 0.0375 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1403 -4 Estradiol Transdermal System, USP 0.05 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1404 -4 Estradiol Transdermal System, USP 0.06 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1405 -4 Estradiol Transdermal System, USP 0.075 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA NDC 70771- 1406 -4 Estradiol Transdermal System, USP 0.1 mg/day Continuous Delivery (Once-Weekly) FOR TRANSDERMAL USE ONLY Contains 4 transdermal systems Rx only zydus Pharmaceuticals USA Estradiol Transdermal System USP, 0.025mg per day Estradiol Transdermal System USP, 0.0375mg per day Estradiol Transdermal System USP, 0.05mg per day Estradiol Transdermal System USP, 0.06mg per day Estradiol Transdermal System USP, 0.075mg per day Estradiol Transdermal System USP, 0.1mg per day

Spl Unclassified Section

SPL UNCLASSIFIED

Drug section

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