Orange Book product · Brand (NDA)
LOTRISONE
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
At a glance
Dec 08, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 08, 2000
25 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Strength
EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
LOTION
Route
TOPICAL
TE code
Not listed
Application
NDA 020010
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.
- 1984LOTRISONEBrand (NDA)
NDA 018827 · ORGANON
- 2015CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 202894 · GLENMARK SPECLT
- 2005CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 076516 · FOUGERA PHARMS
- 2004CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 076493 · SUN PHARMA CANADA
- 2002CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 076002 · ACTAVIS MID ATLANTIC
- 2001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 075502 · FOUGERA PHARMS
- 2001CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEGeneric (ANDA)
ANDA 075673 · TARO
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.
