FDA Orange Book · active-ingredient family
Metolazone
Metolazone is approved as 3 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZAROXOLYN · NDA 017386
3
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZAROXOLYNRLD×3 | I3 PHARMS | NDA 017386 | — | Approved Prior to Jan 1, 1982 | |
| MYKROX | CHARTWELL MOLECULAR | NDA 019532 | — | Oct 30, 1987 | |
| DIULO×3 | GD SEARLE LLC | NDA 018535 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METOLAZONE×3 | MICRO LABS | ANDA 217563 | AB | Nov 06, 2024 | |
| METOLAZONE×3 | IXORA LIFESCIENCE | ANDA 218606 | AB | Apr 17, 2024 | |
| METOLAZONE×3 | NE RX PHARMA | ANDA 216216 | AB | Oct 25, 2022 | |
| METOLAZONE×3 | RENATA | ANDA 215616 | AB | Oct 24, 2022 | |
| METOLAZONE×3 | RUBICON RESEARCH | ANDA 215184 | AB | Aug 20, 2021 | |
| METOLAZONE×3 | INNOGENIX | ANDA 213827 | AB | Mar 30, 2021 | |
| METOLAZONE×3 | UNICHEM | ANDA 214799 | AB | Mar 30, 2021 | |
| METOLAZONE×3 | ALEMBIC | ANDA 213251 | AB | Dec 02, 2020 | |
| METOLAZONE | WATSON LABS | ANDA 076891 | — | Jul 21, 2004 | |
| METOLAZONE | ROXANE | ANDA 076482 | — | Apr 29, 2004 | |
| METOLAZONE×3 | ANI PHARMS | ANDA 075543 | — | Jan 06, 2004 | |
| METOLAZONE×3 | MYLAN | ANDA 076698 | AB | Dec 23, 2003 | |
| METOLAZONE | SANDOZ | ANDA 076732 | AB | Dec 19, 2003 | |
| METOLAZONE×2 | SANDOZ | ANDA 076466 | AB | Dec 19, 2003 |
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.
Metolazone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
