Orange Book product · Brand (NDA)
TOLINASE
TOLAZAMIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
TOLAZAMIDE
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 015500
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.
- 1984TOLAZAMIDEBrand (NDA)
NDA 018894 · COSETTE
- 1988TOLAZAMIDEGeneric (ANDA)
ANDA 071355 · USL PHARMA
- 1987TOLAZAMIDEGeneric (ANDA)
ANDA 071633 · CHARTWELL RX
- 1987TOLAZAMIDEGeneric (ANDA)
ANDA 071357 · SUN PHARM INDUSTRIES
- 1987TOLAZAMIDEGeneric (ANDA)
ANDA 071358 · SUN PHARM INDUSTRIES
- 1987TOLAZAMIDEGeneric (ANDA)
ANDA 071359 · SUN PHARM INDUSTRIES
- 1986TOLAZAMIDEGeneric (ANDA)
ANDA 071270 · INTERPHARM
- 1986TOLAZAMIDEGeneric (ANDA)
ANDA 071271 · INTERPHARM
- 1986TOLAZAMIDEGeneric (ANDA)
ANDA 070242 · WATSON LABS
- 1986TOLAZAMIDEGeneric (ANDA)
ANDA 070243 · WATSON LABS
- 1986TOLAZAMIDEGeneric (ANDA)
ANDA 070244 · WATSON LABS
- 1986TOLAZAMIDEGeneric (ANDA)
ANDA 070763 · SUPERPHARM
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.
