Orange Book product · Brand (NDA)
ZAROXOLYN
METOLAZONE
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
METOLAZONE
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 017386
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.
- 1987MYKROXBrand (NDA)
NDA 019532 · CHARTWELL MOLECULAR
- —DIULOBrand (NDA)
NDA 018535 · GD SEARLE LLC
- 2024METOLAZONEGeneric (ANDA)
ANDA 217563 · MICRO LABS
- 2024METOLAZONEGeneric (ANDA)
ANDA 218606 · IXORA LIFESCIENCE
- 2022METOLAZONEGeneric (ANDA)
ANDA 216216 · NE RX PHARMA
- 2022METOLAZONEGeneric (ANDA)
ANDA 215616 · RENATA
- 2021METOLAZONEGeneric (ANDA)
ANDA 215184 · RUBICON RESEARCH
- 2021METOLAZONEGeneric (ANDA)
ANDA 213827 · INNOGENIX
- 2021METOLAZONEGeneric (ANDA)
ANDA 214799 · UNICHEM
- 2020METOLAZONEGeneric (ANDA)
ANDA 213251 · ALEMBIC
- 2004METOLAZONEGeneric (ANDA)
ANDA 076891 · WATSON LABS
- 2004METOLAZONEGeneric (ANDA)
ANDA 076482 · ROXANE
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.
