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Details for New Drug Application (NDA): 021633

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NDA 021633 describes FEMTRACE, which is a drug marketed by Apil and is included in one NDA. There are three patents protecting this drug. Additional details are available on the FEMTRACE profile page.

The generic ingredient in FEMTRACE is estradiol acetate. There are seventy-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the estradiol acetate profile page.

Summary for NDA: 021633

estradiol acetate
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.45MG
Approval Date:Aug 20, 2004TE:RLD:No
Patent:6,962,908Patent Expiration:Dec 21, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:7,799,771Patent Expiration:Dec 21, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:7,572,779Patent Expiration:Oct 2, 2025Product Flag?Substance Flag?Delist Request?

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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. thinkBiotech performs no independent verifification 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.