FDA Orange Book · active-ingredient family
Cephradine
Cephradine is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VELOSEF '250' · NDA 050548
2
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for suspension, injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VELOSEF '250'×2 | ERSANA | NDA 050548 | — | Approved Prior to Jan 1, 1982 | |
| VELOSEF | BRISTOL MYERS SQUIBB | NDA 050530 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEPHRADINE | BARR | ANDA 062858 | — | May 19, 1988 | |
| CEPHRADINE | BARR | ANDA 062859 | — | May 19, 1988 | |
| CEPHRADINE | BARR | ANDA 062850 | — | Apr 22, 1988 | |
| CEPHRADINE | BARR | ANDA 062851 | — | Apr 22, 1988 | |
| CEPHRADINE×2 | VITARINE | ANDA 062813 | — | Feb 25, 1988 | |
| CEPHRADINE×2 | IVAX SUB TEVA PHARMS | ANDA 062762 | — | Mar 06, 1987 | |
| CEPHRADINE×2 | TEVA | ANDA 062683 | — | Jan 09, 1987 | |
| CEPHRADINE×2 | TEVA | ANDA 062693 | — | Jan 09, 1987 | |
| ANSPOR×2 | GLAXOSMITHKLINE | ANDA 061859 | — | Approved Prior to Jan 1, 1982 | |
| VELOSEF×2 | APOTHECON | ANDA 061764 | — | Approved Prior to Jan 1, 1982 | |
| ANSPOR×2 | GLAXOSMITHKLINE | ANDA 061866 | — | Approved Prior to Jan 1, 1982 | |
| VELOSEF '125'×2 | APOTHECON | ANDA 061763 | — | Approved Prior to Jan 1, 1982 | |
| VELOSEF×5 | APOTHECON | ANDA 061976 | — | 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.
Cephradine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
