Orange Book product · Brand (NDA)
TAVIST
CLEMASTINE FUMARATE
At a glance
Jun 28, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 28, 1985
41 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
CLEMASTINE FUMARATE
Strength
EQ 0.5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
NDA 018675
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.
- 1992TAVIST-1Brand (NDA)
NDA 020925 · HALEON US HOLDINGS
- —TAVISTBrand (NDA)
NDA 017661 · NOVARTIS
- 2000CLEMASTINE FUMARATEGeneric (ANDA)
ANDA 075703 · APOTEX INC
- 1998CLEMASTINE FUMARATEGeneric (ANDA)
ANDA 074863 · WOCKHARDT BIO AG
- 1997CLEMASTINE FUMARATEGeneric (ANDA)
ANDA 074884 · NEW HEIGHTSRX
- 1995CLEMASTINE FUMARATEGeneric (ANDA)
ANDA 074512 · L PERRIGO CO
- 1994CLEMASTINE FUMARATEGeneric (ANDA)
ANDA 073399 · GENUS
- 1993CLEMASTINE FUMARATEGeneric (ANDA)
ANDA 074075 · ACTAVIS MID ATLANTIC
- 1993CLEMASTINE FUMARATEGeneric (ANDA)
ANDA 073459 · OMNIVIUM PHARMS
- 1993CLEMASTINE FUMARATEGeneric (ANDA)
ANDA 073458 · PLD ACQUISITIONS LLC
- 1992CLEMASTINE FUMARATEGeneric (ANDA)
ANDA 073095 · TEVA PHARMS
- 1992CLEMASTINE FUMARATEGeneric (ANDA)
ANDA 073282 · 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.
