Orange Book product · Brand (NDA)
EVISTA
RALOXIFENE HYDROCHLORIDE
At a glance
Dec 09, 1997
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 09, 1997
28 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
RALOXIFENE HYDROCHLORIDE
Strength
60MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020815
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2020RALOXIFENE HYDROCHLORIDEGeneric (ANDA)
ANDA 211324 · CADILA PHARMS LTD
- 2016RALOXIFENE HYDROCHLORIDEGeneric (ANDA)
ANDA 206384 · SCIEGEN PHARMS
- 2016RALOXIFENE HYDROCHLORIDEGeneric (ANDA)
ANDA 208206 · AMNEAL PHARMS
- 2016RALOXIFENE HYDROCHLORIDEGeneric (ANDA)
ANDA 204491 · GLENMARK PHARMS LTD
- 2015RALOXIFENE HYDROCHLORIDEGeneric (ANDA)
ANDA 204310 · AUROBINDO PHARMA
- 2015RALOXIFENE HYDROCHLORIDEGeneric (ANDA)
ANDA 200825 · WATSON LABS INC
- 2014RALOXIFENE HYDROCHLORIDEGeneric (ANDA)
ANDA 090842 · INVAGEN PHARMS
- 2014RALOXIFENE HYDROCHLORIDEGeneric (ANDA)
ANDA 078193 · TEVA PHARMS USA
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.
