Orange Book product · Brand (NDA)
TOLECTIN DS
TOLMETIN SODIUM
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
TOLMETIN SODIUM
Strength
EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 018084
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.
- —TOLECTINBrand (NDA)
NDA 017628 · ORTHO MCNEIL JANSSEN
- 1997TOLMETIN SODIUMGeneric (ANDA)
ANDA 074729 · COSETTE
- 1996TOLMETIN SODIUMGeneric (ANDA)
ANDA 074399 · COSETTE
- 1994TOLMETIN SODIUMGeneric (ANDA)
ANDA 074473 · RISING
- 1993TOLMETIN SODIUMGeneric (ANDA)
ANDA 074002 · CHARTWELL RX
- 1993TOLMETIN SODIUMGeneric (ANDA)
ANDA 073393 · RISING
- 1992TOLMETIN SODIUMGeneric (ANDA)
ANDA 073588 · CHARTWELL RX
- 1992TOLMETIN SODIUMGeneric (ANDA)
ANDA 073527 · ANI PHARMS
- 1992TOLMETIN SODIUMGeneric (ANDA)
ANDA 073519 · ANI PHARMS
- 1992TOLMETIN SODIUMGeneric (ANDA)
ANDA 073462 · CHARTWELL RX
- 1992TOLMETIN SODIUMGeneric (ANDA)
ANDA 073308 · ANI PHARMS
- 1992TOLMETIN SODIUMGeneric (ANDA)
ANDA 073392 · ANI PHARMS
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.
