Orange Book product · Brand (NDA)
NEPTAZANE
METHAZOLAMIDE
At a glance
Nov 25, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 25, 1991
35 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
METHAZOLAMIDE
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 011721
Product number
002
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.
- 2026METHAZOLAMIDEGeneric (ANDA)
ANDA 217408 · AJANTA PHARMA LTD
- 2022METHAZOLAMIDEGeneric (ANDA)
ANDA 215615 · TAGI
- 2018METHAZOLAMIDEGeneric (ANDA)
ANDA 207438 · BAUSCH AND LOMB INC
- 1997METHAZOLAMIDEGeneric (ANDA)
ANDA 040011 · APPLIED ANAL
- 1996METHAZOLAMIDEGeneric (ANDA)
ANDA 040102 · POM PHARMA
- 1994METHAZOLAMIDEGeneric (ANDA)
ANDA 040062 · ANDA REPOSITORY
- 1993METHAZOLAMIDEGeneric (ANDA)
ANDA 040001 · ANI PHARMS
- 1993METHAZOLAMIDEGeneric (ANDA)
ANDA 040036 · CHARTWELL RX
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.
