You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209767

✉ Email this page to a colleague

« Back to Dashboard

NDA 209767 describes ESTRADIOL, which is a drug marketed by Encube, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Novitium Pharma, Solaris Pharma Corp, Chemo Research Sl, Quagen, Ortho Mcneil Pharm, Barr Labs Inc, Epic Pharma Llc, Lannett Co Inc, Pharmobedient, Rubicon Research, Usl Pharma, Amneal Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Barr, Breckenridge Pharm, Naari Pte, Novast Labs, Xiromed, Dr Reddys, Am Regent, Fosun Pharma, Hikma, and Watson Labs, and is included in forty-nine NDAs. It is available from thirty-five suppliers. Additional details are available on the ESTRADIOL profile page.

The generic ingredient in ESTRADIOL is estradiol valerate. There are seventy-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.

Summary for 209767

Tradename:	ESTRADIOL
Applicant:	Encube
Ingredient:	estradiol
Patents:	0

Pharmacology for NDA: 209767

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 209767

Estrogens

Suppliers and Packaging for NDA: 209767

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ESTRADIOL	estradiol	CREAM;VAGINAL	209767	ANDA	Encube Ethicals, Inc.	21922-085	21922-085-06	1 TUBE in 1 CARTON (21922-085-06) / 42.5 g in 1 TUBE
ESTRADIOL	estradiol	CREAM;VAGINAL	209767	ANDA	Alvogen Inc.	47781-104	47781-104-44	1 TUBE, WITH APPLICATOR in 1 CARTON (47781-104-44) / 42.5 g in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;VAGINAL			Strength	0.01%
Approval Date:	Mar 5, 2018	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.