Assyro AI

FDA Orange Book · active-ingredient family

Tolmetin sodium

Tolmetin sodium is approved as 2 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TOLECTIN DS · NDA 018084

2

Brand (NDA)

14

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, tablet

ProductApplicantApplicationTEApproved
TOLECTIN DSRLDORTHO MCNEIL JANSSENNDA 018084—Approved Prior to Jan 1, 1982
TOLECTINRLD×2ORTHO MCNEIL JANSSENNDA 017628—Approved Prior to Jan 1, 1982

Generic (ANDA) products (14)

ProductApplicantApplicationTEApproved
TOLMETIN SODIUMCOSETTEANDA 074729—Feb 27, 1997
TOLMETIN SODIUMCOSETTEANDA 074399—Mar 28, 1996
TOLMETIN SODIUMRISINGANDA 074473—Aug 30, 1994
TOLMETIN SODIUMCHARTWELL RXANDA 074002—Sep 27, 1993
TOLMETIN SODIUMRISINGANDA 073393—May 27, 1993
TOLMETIN SODIUMCHARTWELL RXANDA 073588—Jul 31, 1992
TOLMETIN SODIUMANI PHARMSANDA 073527—Jun 30, 1992
TOLMETIN SODIUMANI PHARMSANDA 073519—May 29, 1992
TOLMETIN SODIUMCHARTWELL RXANDA 073462—Apr 30, 1992
TOLMETIN SODIUMANI PHARMSANDA 073308—Jan 24, 1992
TOLMETIN SODIUMANI PHARMSANDA 073392—Jan 24, 1992
TOLMETIN SODIUMSENORES PHARMSANDA 073290—Nov 27, 1991
TOLMETIN SODIUMSUN PHARM INDUSTRIESANDA 073311—Nov 27, 1991
TOLMETIN SODIUMSUN PHARM INDUSTRIESANDA 073310—Nov 27, 1991

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.

Tolmetin sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo