Orange Book product · Brand (NDA)
NOLVADEX
TAMOXIFEN CITRATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
TAMOXIFEN CITRATE
Strength
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 017970
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2005SOLTAMOXBrand (NDA)
NDA 021807 · MAYNE PHARMA COMMRCL
- 2020TAMOXIFEN CITRATEGeneric (ANDA)
ANDA 213358 · EUGIA PHARMA
- 2017TAMOXIFEN CITRATEGeneric (ANDA)
ANDA 206694 · ZYDUS PHARMS
- 2011TAMOXIFEN CITRATEGeneric (ANDA)
ANDA 090878 · APOTEX
- 2003TAMOXIFEN CITRATEGeneric (ANDA)
ANDA 074504 · TEVA
- 2003TAMOXIFEN CITRATEGeneric (ANDA)
ANDA 076398 · AEGIS PHARMS
- 2003TAMOXIFEN CITRATEGeneric (ANDA)
ANDA 074539 · PHARMACHEMIE
- 2003TAMOXIFEN CITRATEGeneric (ANDA)
ANDA 070929 · ACTAVIS LABS FL INC
- 2003TAMOXIFEN CITRATEGeneric (ANDA)
ANDA 076179 · ACTAVIS LABS FL INC
- 2003TAMOXIFEN CITRATEGeneric (ANDA)
ANDA 075797 · DR REDDYS LABS SA
- 2003TAMOXIFEN CITRATEGeneric (ANDA)
ANDA 075740 · IVAX SUB TEVA PHARMS
- 2003TAMOXIFEN CITRATEGeneric (ANDA)
ANDA 074732 · MYLAN
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
