FDA Orange Book · active-ingredient family
Clemastine fumarate
Clemastine fumarate is approved as 3 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TAVIST-1 · NDA 020925
3
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · syrup, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TAVIST-1RLD | HALEON US HOLDINGS | NDA 020925 | — | Aug 21, 1992 | |
| TAVISTRLD | NOVARTIS | NDA 018675 | — | Jun 28, 1985 | |
| TAVISTRLD×3 | NOVARTIS | NDA 017661 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLEMASTINE FUMARATE | APOTEX INC | ANDA 075703 | — | Nov 27, 2000 | |
| CLEMASTINE FUMARATE | WOCKHARDT BIO AG | ANDA 074863 | — | Mar 13, 1998 | |
| CLEMASTINE FUMARATE | NEW HEIGHTSRX | ANDA 074884 | AA | Dec 17, 1997 | |
| CLEMASTINE FUMARATE | L PERRIGO CO | ANDA 074512 | — | Nov 22, 1995 | |
| CLEMASTINE FUMARATE | GENUS | ANDA 073399 | AA | Jun 30, 1994 | |
| CLEMASTINE FUMARATE | ACTAVIS MID ATLANTIC | ANDA 074075 | — | Oct 31, 1993 | |
| CLEMASTINE FUMARATE | OMNIVIUM PHARMS | ANDA 073459 | — | Oct 31, 1993 | |
| CLEMASTINE FUMARATE | PLD ACQUISITIONS LLC | ANDA 073458 | — | Oct 31, 1993 | |
| CLEMASTINE FUMARATE | TEVA PHARMS | ANDA 073095 | — | Apr 21, 1992 | |
| CLEMASTINE FUMARATE×2 | ANI PHARMS | ANDA 073282 | — | Jan 31, 1992 | |
| CLEMASTINE FUMARATE | GENUS | ANDA 073283 | — | Jan 31, 1992 |
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.
Clemastine fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
