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

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PharmaCompass

01

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Not Confirmed

ESTRADIOL

Brand Name : ALORA

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 0.05MG/24HR

Approval Date : 1996-12-20

Application Number : 20655

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Abbvie Company Banner

02

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Not Confirmed

ESTRADIOL

Brand Name : ESTRACE

Dosage Form : CREAM;VAGINAL

Dosage Strength : 0.01%

Approval Date : 1984-01-31

Application Number : 86069

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Abbvie CB

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

ESTRADIOL

Brand Name : ESTRADIOL

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 1996-03-14

Application Number : 40114

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

04

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Not Confirmed

ESTRADIOL; NORETHINDRONE ACETATE

Brand Name : ESTRADIOL AND NORETHINDRONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG;0.5MG

Approval Date : 2008-04-17

Application Number : 78324

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

05

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Not Confirmed

ESTRADIOL

Brand Name : ALORA

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 0.075MG/24HR

Approval Date : 1996-12-20

Application Number : 20655

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Abbvie Company Banner

06

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Not Confirmed

ESTRADIOL

Brand Name : ALORA

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 0.1MG/24HR

Approval Date : 1996-12-20

Application Number : 20655

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Abbvie Company Banner

07

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Not Confirmed

ESTRADIOL

Brand Name : ALORA

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 0.025MG/24HR

Approval Date : 2002-04-05

Application Number : 20655

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Abbvie Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

ESTRADIOL

Brand Name : ESTRADIOL

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Approval Date : 1996-03-14

Application Number : 40114

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

ESTRADIOL

Brand Name : ESTRADIOL

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 1996-03-14

Application Number : 40114

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

10

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Formnext Forum
Not Confirmed

ESTRADIOL; NORETHINDRONE ACETATE

Brand Name : ESTRADIOL AND NORETHINDRONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG;0.1MG

Approval Date : 2011-06-09

Application Number : 78324

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical