FDA Orange Book · active-ingredient family
Methazolamide
Methazolamide is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NEPTAZANE · NDA 011721
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEPTAZANERLD×2 | LEDERLE | NDA 011721 | — | Nov 25, 1991 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHAZOLAMIDE×2 | AJANTA PHARMA LTD | ANDA 217408 | AB | Feb 09, 2026 | |
| METHAZOLAMIDE×2 | TAGI | ANDA 215615 | AB | Oct 18, 2022 | |
| METHAZOLAMIDE×2 | BAUSCH AND LOMB INC | ANDA 207438 | AB | Oct 05, 2018 | |
| METHAZOLAMIDE×2 | APPLIED ANAL | ANDA 040011 | — | Jul 17, 1997 | |
| METHAZOLAMIDE×2 | POM PHARMA | ANDA 040102 | — | Aug 28, 1996 | |
| METHAZOLAMIDE×2 | ANDA REPOSITORY | ANDA 040062 | AB | Jan 27, 1994 | |
| METHAZOLAMIDE×2 | ANI PHARMS | ANDA 040001 | AB | Jun 30, 1993 | |
| METHAZOLAMIDE×2 | CHARTWELL RX | ANDA 040036 | AB | Jun 30, 1993 |
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.
Methazolamide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
