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Details for New Drug Application (NDA): 021048

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NDA 021048 describes ESTRADIOL, which is a drug marketed by Mayne Pharma, Mylan, Lannett Holdings Inc, Ortho Mcneil Pharm, Amneal Pharms, Mylan Technologies, Epic Pharma Inc, Barr Labs Inc, Usl Pharma, Breckenridge Pharm, Teva Pharms Usa, Barr, Watson Labs, Luitpold, Sandoz, and Watson Labs Inc, and is included in twenty-one NDAs. It is available from twenty-eight suppliers. Additional details are available on the ESTRADIOL profile page.

The generic ingredient in ESTRADIOL is dienogest; estradiol valerate. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dienogest; estradiol valerate profile page.

Summary for NDA: 021048

Summary for product number 001

Approval Date:Sep 20, 1999TE:RLD:No

Summary for product number 002

Approval Date:Sep 20, 1999TE:RLD:No

Summary for product number 003

Approval Date:Sep 20, 1999TE:RLD:No

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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.