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Details for New Drug Application (NDA): 090878

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NDA 090878 describes TAMOXIFEN CITRATE, which is a drug marketed by Teva, Roxane, Actavis Labs Fl Inc, Mylan, Pharmachemie, Ivax Sub Teva Pharms, Mayne Pharma, Apotex, and Aegis Pharms, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the TAMOXIFEN CITRATE profile page.

The generic ingredient in TAMOXIFEN CITRATE is tamoxifen citrate. There are sixteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.

Summary for NDA: 090878

tamoxifen citrate
Therapeutic Class:Antineoplastics

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Sep 23, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Sep 23, 2011TE:ABRLD: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.