FDA Orange Book · active-ingredient family
Phenazopyridine hydrochloride; sulfisoxazole
Phenazopyridine hydrochloride; sulfisoxazole: 1 brand, 0 generics; first approved Aug 31, 1990.
Brand onlyHas discontinued products
Generic status & protection
No listed patents or exclusivity: brand product(s) only.
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
1
Brand (NDA) products
Originator applications
- ROCHENDA 0193581990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG;500MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
36 yr 5 mo ago
Most recent approval
36 yr 5 mo ago
All 1 application were approved in 1990.
Brand (NDA) 1100%
Generic (ANDA) 00%
Phenazopyridine hydrochloride; sulfisoxazole: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
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