Orange Book product · Generic (ANDA)
METOLAZONE
METOLAZONE
At a glance
Dec 19, 2003
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 2003
22 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
METOLAZONE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 076466
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of METOLAZONE
- 1987MYKROXBrand (NDA)
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- —DIULOBrand (NDA)
NDA 018535 · GD SEARLE LLC
- —ZAROXOLYNBrand (NDA)
NDA 017386 · I3 PHARMS
- 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
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.

