Orange Book product · Generic (ANDA)
CLEMASTINE FUMARATE
CLEMASTINE FUMARATE
At a glance
Mar 13, 1998
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 13, 1998
28 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CLEMASTINE FUMARATE
Strength
EQ 0.5MG BASE/5ML
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
ANDA 074863
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CLEMASTINE FUMARATE
- 1992TAVIST-1Brand (NDA)
NDA 020925 · HALEON US HOLDINGS
- 1985TAVISTBrand (NDA)
NDA 018675 · NOVARTIS
- —TAVISTBrand (NDA)
NDA 017661 · NOVARTIS
- 2000CLEMASTINE FUMARATEGeneric (ANDA)
ANDA 075703 · APOTEX INC
- 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.

