FDA Orange Book · active-ingredient family
Fenoprofen calcium
Fenoprofen calcium is approved as 2 brand and 32 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NALFON · NDA 017604
2
Brand (NDA)
32
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NALFONRLD×3 | PHARMACO | NDA 017604 | — | Approved Prior to Jan 1, 1982 | |
| NALFONRLD | DISTA | NDA 017710 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (32)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FENOPROFEN CALCIUM×3 | RISING | ANDA 214475 | — | Jul 26, 2024 | |
| FENOPROFEN CALCIUM×3 | MISEMER | ANDA 215548 | — | May 16, 2023 | |
| FENOPROFEN CALCIUM | WATSON LABS | ANDA 072981 | — | Aug 19, 1991 | |
| FENOPROFEN CALCIUM | WATSON LABS | ANDA 072982 | — | Aug 19, 1991 | |
| FENOPROFEN CALCIUM | WARNER CHILCOTT | ANDA 072946 | — | Apr 30, 1991 | |
| FENOPROFEN CALCIUM | WARNER CHILCOTT | ANDA 072472 | — | Apr 30, 1991 | |
| FENOPROFEN CALCIUM | SUN PHARM INDUSTRIES | ANDA 072902 | — | Dec 21, 1990 | |
| FENOPROFEN CALCIUM | RISING | ANDA 072394 | — | Oct 17, 1988 | |
| FENOPROFEN CALCIUM | RISING | ANDA 072395 | — | Oct 17, 1988 | |
| FENOPROFEN CALCIUM | RISING | ANDA 072396 | — | Oct 17, 1988 | |
| FENOPROFEN CALCIUM | WATSON LABS | ANDA 072602 | — | Oct 11, 1988 | |
| FENOPROFEN CALCIUM | IVAX SUB TEVA PHARMS | ANDA 072557 | — | Aug 29, 1988 | |
| FENOPROFEN CALCIUM | AM THERAP | ANDA 072307 | — | Aug 22, 1988 | |
| FENOPROFEN CALCIUM | AM THERAP | ANDA 072308 | — | Aug 22, 1988 | |
| FENOPROFEN CALCIUM | PAR PHARM | ANDA 072437 | — | Aug 22, 1988 | |
| FENOPROFEN CALCIUM | PAR PHARM | ANDA 072438 | — | Aug 22, 1988 | |
| FENOPROFEN CALCIUM | HALSEY | ANDA 072355 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | HALSEY | ANDA 072356 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | QUANTUM PHARMICS | ANDA 072214 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | QUANTUM PHARMICS | ANDA 071738 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | WATSON LABS | ANDA 072294 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | WATSON LABS | ANDA 072293 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | AM THERAP | ANDA 072309 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | DAVA PHARMS INC | ANDA 072326 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | HALSEY | ANDA 072357 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | PHARMACO | ANDA 072267 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | QUANTUM PHARMICS | ANDA 072194 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | STRIDES PHARMA INTL | ANDA 072429 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | USL PHARMA | ANDA 072362 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | WATSON LABS | ANDA 072165 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | WATSON LABS TEVA | ANDA 072407 | — | Aug 17, 1988 | |
| FENOPROFEN CALCIUM | ANI PHARMS | ANDA 072274 | — | May 02, 1988 |
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.
Fenoprofen calcium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
