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Estradiol valerateis the generic ingredient in four branded drugs marketed by Par Sterile Products, Am Regent, Dr Reddys, Fosun Pharma, Hikma, Watson Labs, and Savage Labs, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.
There are seventy-five drug master file entries for estradiol valerate. Four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ESTRADIOL VALERATE
|Drug Master File Entries:||75|
|Suppliers / Packagers:||4|
|Bulk Api Vendors:||57|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for ESTRADIOL VALERATE|
|DailyMed Link:||ESTRADIOL VALERATE at DailyMed|
Recent Clinical Trials for ESTRADIOL VALERATE
Identify potential brand extensions & 505(b)(2) entrants
|University of California, San Diego||Phase 4|
|Cairo University||Phase 1|
|University Hospital, Ghent||Phase 3|
Generic filers with tentative approvals for ESTRADIOL VALERATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for ESTRADIOL VALERATE
|Drug Class||Estrogen |
|Mechanism of Action||Estrogen Receptor Agonists |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Watson Labs||TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE||estradiol valerate; testosterone enanthate||INJECTABLE;INJECTION||085865-001||Approved Prior to Jan 1, 1982||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Am Regent||ESTRADIOL VALERATE||estradiol valerate||INJECTABLE;INJECTION||090920-002||Jan 19, 2010||AO||RX||No||No||Start Trial||Start Trial||Start Trial|
|Fosun Pharma||ESTRADIOL VALERATE||estradiol valerate||INJECTABLE;INJECTION||040628-001||Oct 4, 2007||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
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