Orange Book product · Brand (NDA)
ACLOVATE
ALCLOMETASONE DIPROPIONATE
At a glance
Dec 14, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 14, 1982
44 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ALCLOMETASONE DIPROPIONATE
Strength
0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 018707
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.
- 1982ACLOVATEBrand (NDA)
NDA 018702 · FOUGERA PHARMS
- 2009ALCLOMETASONE DIPROPIONATEGeneric (ANDA)
ANDA 079227 · GLENMARK PHARMS LTD
- 2009ALCLOMETASONE DIPROPIONATEGeneric (ANDA)
ANDA 079061 · GLENMARK PHARMS LTD
- 2005ALCLOMETASONE DIPROPIONATEGeneric (ANDA)
ANDA 076587 · SUN PHARMA CANADA
- 2005ALCLOMETASONE DIPROPIONATEGeneric (ANDA)
ANDA 076884 · FOUGERA PHARMS
- 2005ALCLOMETASONE DIPROPIONATEGeneric (ANDA)
ANDA 076973 · FOUGERA PHARMS
- 2004ALCLOMETASONE DIPROPIONATEGeneric (ANDA)
ANDA 076730 · SUN PHARMA CANADA
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.
