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FDA Orange Book · active-ingredient family

Sulfacetamide sodium

Sulfacetamide sodium is approved as 2 brand and 28 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:KLARON · NDA 019931

2

Brand (NDA)

28

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · lotion, ointment, solution/drops

ProductApplicantApplicationTEApproved
KLARONRLDBAUSCHNDA 019931ABDec 23, 1996
SODIUM SULAMYDRLD×3SCHERINGNDA 005963—Approved Prior to Jan 1, 1982

Generic (ANDA) products (28)

ProductApplicantApplicationTEApproved
SULFACETAMIDE SODIUMSUN PHARMA CANADAANDA 078668—May 20, 2009
SULFACETAMIDE SODIUMPADAGIS USANDA 078649ABMar 23, 2009
SULFACETAMIDE SODIUMFOUGERA PHARMSANDA 077015ABNov 17, 2006
SULFACETAMIDE SODIUMEPIC PHARMA LLCANDA 040216—May 25, 1999
SULFACETAMIDE SODIUMPHARMOBEDIENTANDA 040215—May 25, 1999
SULF-15NOVARTISANDA 089047—Oct 31, 1995
SULFACETAMIDE SODIUMBAUSCH AND LOMBANDA 040066ATDec 28, 1994
SULFACETAMIDE SODIUMCHARTWELL RXANDA 089560ATOct 18, 1988
SULFACETAMIDE SODIUMALCON PHARMS LTDANDA 089068—May 05, 1987
SULFACETAMIDE SODIUMPHARMAFAIRANDA 088947—May 17, 1985
SULFAIR FORTEPHARMAFAIRANDA 088385—Oct 13, 1983
SULFAIR-15PHARMAFAIRANDA 088186—May 25, 1983
SULTEN-10BAUSCH AND LOMBANDA 087818—Feb 03, 1983
SULFAIR 10PHARMAFAIRANDA 088000—Dec 22, 1982
SULFAIR 10PHARMAFAIRANDA 087949—Dec 13, 1982
BLEPH-10ALLERGANANDA 084015—Approved Prior to Jan 1, 1982
CETAMIDEALCONANDA 080021—Approved Prior to Jan 1, 1982
SULFACETAMIDE SODIUMPADAGIS USANDA 080029—Approved Prior to Jan 1, 1982
BLEPH-10RLD×2ALLERGANANDA 080028—Approved Prior to Jan 1, 1982
ISOPTO CETAMIDEALCONANDA 080020—Approved Prior to Jan 1, 1982
OCUSULF-10×2MIZA PHARMS USAANDA 080660—Approved Prior to Jan 1, 1982
SODIUM SULFACETAMIDE×3EPIC PHARMA LLCANDA 083021—Approved Prior to Jan 1, 1982
SODIUM SULFACETAMIDESOLA BARNES HINDANDA 084143—Approved Prior to Jan 1, 1982
SODIUM SULFACETAMIDESOLA BARNES HINDANDA 084145—Approved Prior to Jan 1, 1982
SODIUM SULFACETAMIDESOLA BARNES HINDANDA 084146—Approved Prior to Jan 1, 1982
SODIUM SULFACETAMIDESOLA BARNES HINDANDA 084147—Approved Prior to Jan 1, 1982
SULF-10NOVARTISANDA 080025—Approved Prior to Jan 1, 1982
SULFACEL-15OPTOPICSANDA 080024—Approved Prior to Jan 1, 1982

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.

Sulfacetamide sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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