Orange Book product · Brand (NDA)
EVOXAC
CEVIMELINE HYDROCHLORIDE
At a glance
Jan 11, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 11, 2000
26 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
CEVIMELINE HYDROCHLORIDE
Strength
30MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 020989
Product number
002
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.
- 2026CEVIMELINE HYDROCHLORIDEGeneric (ANDA)
ANDA 220267 · ZYDUS LIFESCIENCES
- 2024CEVIMELINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206808 · MACLEODS PHARMS LTD
- 2023CEVIMELINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218290 · BIONPHARMA
- 2023CEVIMELINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215056 · AUROBINDO PHARMA
- 2023CEVIMELINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216682 · RUBICON RESEARCH
- 2016CEVIMELINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204746 · NOVEL LABS INC
- 2014CEVIMELINE HYDROCHLORIDEGeneric (ANDA)
ANDA 203775 · RISING
- 2013CEVIMELINE HYDROCHLORIDEGeneric (ANDA)
ANDA 091591 · HIKMA
- 2011CEVIMELINE HYDROCHLORIDEGeneric (ANDA)
ANDA 091260 · APOTEX INC
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.
