Orange Book product · Brand (NDA)
SODIUM SULAMYD
SULFACETAMIDE SODIUM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
SULFACETAMIDE SODIUM
Strength
10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
OINTMENT
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 005963
Product number
002
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.
- 1996KLARONBrand (NDA)
NDA 019931 · BAUSCH
- 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.
