Orange Book product · Brand (NDA)
CLINORIL
SULINDAC
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
SULINDAC
Strength
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 017911
Product number
001
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.
- 1993SULINDACGeneric (ANDA)
ANDA 073039 · RISING
- 1992SULINDACGeneric (ANDA)
ANDA 072973 · ANI PHARMS
- 1991SULINDACGeneric (ANDA)
ANDA 073262 · EPIC PHARMA LLC
- 1991SULINDACGeneric (ANDA)
ANDA 072712 · CHARTWELL RX
- 1991SULINDACGeneric (ANDA)
ANDA 072713 · CHARTWELL RX
- 1991SULINDACGeneric (ANDA)
ANDA 072050 · SUN PHARM INDUSTRIES
- 1991SULINDACGeneric (ANDA)
ANDA 072051 · SUN PHARM INDUSTRIES
- 1991SULINDACGeneric (ANDA)
ANDA 072711 · EPIC PHARMA
- 1990SULINDACGeneric (ANDA)
ANDA 071891 · WATSON LABS
- 1990SULINDACGeneric (ANDA)
ANDA 071795 · WATSON LABS
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.
