FDA Orange Book · active-ingredient family
Tolazamide
Tolazamide is approved as 2 brand and 29 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TOLINASE · NDA 015500
2
Brand (NDA)
29
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOLINASERLD×3 | PHARMACIA AND UPJOHN | NDA 015500 | — | Approved Prior to Jan 1, 1982 | |
| TOLAZAMIDE×3 | COSETTE | NDA 018894 | — | Nov 02, 1984 |
Generic (ANDA) products (29)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOLAZAMIDE | USL PHARMA | ANDA 071355 | — | Jan 11, 1988 | |
| TOLAZAMIDE | CHARTWELL RX | ANDA 071633 | — | Dec 09, 1987 | |
| TOLAZAMIDE | SUN PHARM INDUSTRIES | ANDA 071357 | — | Jul 16, 1987 | |
| TOLAZAMIDE | SUN PHARM INDUSTRIES | ANDA 071358 | — | Jul 16, 1987 | |
| TOLAZAMIDE | SUN PHARM INDUSTRIES | ANDA 071359 | — | Jul 16, 1987 | |
| TOLAZAMIDE | INTERPHARM | ANDA 071270 | — | Sep 23, 1986 | |
| TOLAZAMIDE | INTERPHARM | ANDA 071271 | — | Sep 23, 1986 | |
| TOLAZAMIDE | WATSON LABS | ANDA 070242 | — | Aug 01, 1986 | |
| TOLAZAMIDE | WATSON LABS | ANDA 070243 | — | Aug 01, 1986 | |
| TOLAZAMIDE | WATSON LABS | ANDA 070244 | — | Aug 01, 1986 | |
| TOLAZAMIDE | SUPERPHARM | ANDA 070763 | — | Jun 16, 1986 | |
| TOLAZAMIDE | SUPERPHARM | ANDA 070764 | — | Jun 16, 1986 | |
| TOLAZAMIDE | USL PHARMA | ANDA 070168 | — | Apr 02, 1986 | |
| TOLAZAMIDE | USL PHARMA | ANDA 070169 | — | Apr 02, 1986 | |
| TOLAZAMIDE | CHARTWELL RX | ANDA 070289 | — | Mar 13, 1986 | |
| TOLAZAMIDE | CHARTWELL RX | ANDA 070290 | — | Mar 13, 1986 | |
| TOLAZAMIDE | BARR | ANDA 070162 | — | Jan 14, 1986 | |
| TOLAZAMIDE | BARR | ANDA 070163 | — | Jan 14, 1986 | |
| TOLAZAMIDE | BARR | ANDA 070164 | — | Jan 14, 1986 | |
| TOLAZAMIDE | DURAMED PHARMS BARR | ANDA 070165 | — | Jan 10, 1986 | |
| TOLAZAMIDE | DURAMED PHARMS BARR | ANDA 070166 | — | Jan 10, 1986 | |
| TOLAZAMIDE | DURAMED PHARMS BARR | ANDA 070167 | — | Jan 10, 1986 | |
| TOLAZAMIDE | WATSON LABS | ANDA 070513 | — | Jan 09, 1986 | |
| TOLAZAMIDE | WATSON LABS | ANDA 070514 | — | Jan 09, 1986 | |
| TOLAZAMIDE | WATSON LABS | ANDA 070515 | — | Jan 09, 1986 | |
| TOLAZAMIDE | PAR PHARM | ANDA 070159 | — | Jan 06, 1986 | |
| TOLAZAMIDE | PAR PHARM | ANDA 070160 | — | Jan 06, 1986 | |
| TOLAZAMIDE | PAR PHARM | ANDA 070161 | — | Jan 06, 1986 | |
| TOLAZAMIDE×2 | NATCO | ANDA 070259 | — | Jan 02, 1986 |
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.
Tolazamide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
