FDA Orange Book · active-ingredient family
Methyclothiazide
Methyclothiazide is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ENDURON · NDA 012524
2
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ENDURONRLD×2 | ABBVIE | NDA 012524 | — | Approved Prior to Jan 1, 1982 | |
| AQUATENSEN | MEDPOINTE PHARM HLC | NDA 017364 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHYCLOTHIAZIDE | CHARTWELL RX | ANDA 089835 | — | Aug 18, 1988 | |
| METHYCLOTHIAZIDE | CHARTWELL RX | ANDA 089837 | — | Aug 18, 1988 | |
| METHYCLOTHIAZIDE | PAR PHARM | ANDA 089135 | — | Feb 12, 1986 | |
| METHYCLOTHIAZIDE | PAR PHARM | ANDA 089136 | — | Feb 12, 1986 | |
| METHYCLOTHIAZIDE | USL PHARMA | ANDA 088745 | — | Mar 21, 1985 | |
| METHYCLOTHIAZIDE | WATSON LABS | ANDA 088750 | — | Sep 06, 1984 | |
| METHYCLOTHIAZIDE | WATSON LABS | ANDA 088724 | — | Sep 06, 1984 | |
| METHYCLOTHIAZIDE | MYLAN | ANDA 087671 | — | Aug 17, 1982 | |
| METHYCLOTHIAZIDE | PHARMOBEDIENT | ANDA 087672 | — | Aug 17, 1982 | |
| METHYCLOTHIAZIDE | IVAX PHARMS | ANDA 087913 | — | Jun 03, 1982 | |
| METHYCLOTHIAZIDE | IVAX PHARMS | ANDA 087786 | — | May 18, 1982 | |
| METHYCLOTHIAZIDE | WATSON LABS | ANDA 085487 | — | Mar 11, 1982 | |
| METHYCLOTHIAZIDE | WATSON LABS | ANDA 085476 | — | Mar 11, 1982 |
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.
Methyclothiazide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
