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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 070929


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NDA 070929 describes TAMOXIFEN CITRATE, which is a drug marketed by Actavis Labs Fl Inc, Aegis Pharms, Apotex, Dr Reddys Labs Sa, Eugia Pharma, Ivax Sub Teva Pharms, Mylan, Pharmachemie, Roxane, Teva, and Zydus Pharms, and is included in twelve NDAs. It is available from thirteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.
Summary for 070929
Tradename:TAMOXIFEN CITRATE
Applicant:Actavis Labs Fl Inc
Ingredient:tamoxifen citrate
Patents:0
Pharmacology for NDA: 070929
Suppliers and Packaging for NDA: 070929
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 070929 ANDA Actavis Pharma, Inc. 0591-2472 0591-2472-18 180 TABLET in 1 BOTTLE, PLASTIC (0591-2472-18)
TAMOXIFEN CITRATE tamoxifen citrate TABLET;ORAL 070929 ANDA Actavis Pharma, Inc. 0591-2472 0591-2472-60 60 TABLET in 1 BOTTLE, PLASTIC (0591-2472-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Feb 20, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Feb 20, 2003TE:ABRLD:No

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