Assyro AI

FDA Orange Book · active-ingredient family

Sulfisoxazole

Sulfisoxazole is approved as 1 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:GANTRISIN · NDA 006525

1

Brand (NDA)

18

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
GANTRISINROCHENDA 006525—Approved Prior to Jan 1, 1982

Generic (ANDA) products (18)

ProductApplicantApplicationTEApproved
SOSOLMK LABSANDA 080036—Approved Prior to Jan 1, 1982
SOXAZOLEALRAANDA 080366—Approved Prior to Jan 1, 1982
SULFALARPARKE DAVISANDA 084955—Approved Prior to Jan 1, 1982
SULFISOXAZOLEANI PHARMSANDA 080142—Approved Prior to Jan 1, 1982
SULFISOXAZOLEBARRANDA 084031—Approved Prior to Jan 1, 1982
SULFISOXAZOLEHEATHERANDA 080189—Approved Prior to Jan 1, 1982
SULFISOXAZOLEIMPAX LABSANDA 080109—Approved Prior to Jan 1, 1982
SULFISOXAZOLELANNETTANDA 080085—Approved Prior to Jan 1, 1982
SULFISOXAZOLELEDERLEANDA 087649—Approved Prior to Jan 1, 1982
SULFISOXAZOLEPHARMERALANDA 084385—Approved Prior to Jan 1, 1982
SULFISOXAZOLEPUREPAC PHARMANDA 080087—Approved Prior to Jan 1, 1982
SULFISOXAZOLERISINGANDA 085628—Approved Prior to Jan 1, 1982
SULFISOXAZOLEROXANEANDA 080082—Approved Prior to Jan 1, 1982
SULFISOXAZOLEVALEANT PHARM INTLANDA 080268—Approved Prior to Jan 1, 1982
SULFISOXAZOLEVITARINEANDA 087332—Approved Prior to Jan 1, 1982
SULFISOXAZOLEWATSON LABSANDA 085534—Approved Prior to Jan 1, 1982
SULFISOXAZOLEWEST WARDANDA 080379—Approved Prior to Jan 1, 1982
SULSOXINSOLVAYANDA 080040—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.

Sulfisoxazole — frequently asked questions

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

Agent CTA Background

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