Orange Book product · Brand (NDA)
LOTRISONE
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
At a glance
Jul 10, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 10, 1984
42 yr 7 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EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 018827
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.
- 2000LOTRISONEBrand (NDA)
NDA 020010 · MERCK SHARP DOHME
- 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.
