Orange Book product · Brand (NDA)
KLARON
SULFACETAMIDE SODIUM
At a glance
Dec 23, 1996
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 1996
29 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
SULFACETAMIDE SODIUM
Strength
10%
Dosage form
LOTION
Route
TOPICAL
TE code
AB
Application
NDA 019931
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- —SODIUM SULAMYDBrand (NDA)
NDA 005963 · SCHERING
- 2009SULFACETAMIDE SODIUMGeneric (ANDA)
ANDA 078668 · SUN PHARMA CANADA
- 2009SULFACETAMIDE SODIUMGeneric (ANDA)
ANDA 078649 · PADAGIS US
- 2006SULFACETAMIDE SODIUMGeneric (ANDA)
ANDA 077015 · FOUGERA PHARMS
- 1999SULFACETAMIDE SODIUMGeneric (ANDA)
ANDA 040216 · EPIC PHARMA LLC
- 1999SULFACETAMIDE SODIUMGeneric (ANDA)
ANDA 040215 · PHARMOBEDIENT
- 1995SULF-15Generic (ANDA)
ANDA 089047 · NOVARTIS
- 1994SULFACETAMIDE SODIUMGeneric (ANDA)
ANDA 040066 · BAUSCH AND LOMB
- 1988SULFACETAMIDE SODIUMGeneric (ANDA)
ANDA 089560 · CHARTWELL RX
- 1987SULFACETAMIDE SODIUMGeneric (ANDA)
ANDA 089068 · ALCON PHARMS LTD
- 1985SULFACETAMIDE SODIUMGeneric (ANDA)
ANDA 088947 · PHARMAFAIR
- 1983SULFAIR FORTEGeneric (ANDA)
ANDA 088385 · PHARMAFAIR
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.
