FDA Orange Book · active-ingredient family
Epinephrine; lidocaine hydrochloride
Epinephrine; lidocaine hydrochloride is approved as 6 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:XYLOCAINE W/ EPINEPHRINE · NDA 006488
6
Brand (NDA)
26
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, patch, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XYLOCAINE W/ EPINEPHRINERLD×7 | FRESENIUS KABI USA | NDA 006488 | AP | Approved Prior to Jan 1, 1982 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EMPI | NDA 021486 | — | Oct 26, 2004 | |
| LIDOSITE TOPICAL SYSTEM KIT | VYTERIS | NDA 021504 | — | May 06, 2004 | |
| IONTOCAINE | IOMED | NDA 020530 | — | Dec 21, 1995 | |
| XYLOCAINE DENTAL WITH EPINEPHRINE×2 | DENTSPLY PHARM | NDA 021381 | — | Approved Prior to Jan 1, 1982 | |
| XYLOCAINE W/ EPINEPHRINE×3 | ASTRAZENECA | NDA 010418 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (26)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | B BRAUN MEDICAL | ANDA 208475 | AP | Sep 08, 2021 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE×2 | HOSPIRA | ANDA 078772 | — | May 12, 2008 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE×2 | EASTMAN KODAK | ANDA 040057 | — | Feb 26, 1993 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 089635 | AP | Jun 21, 1988 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 089649 | — | Jun 21, 1988 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 089645 | AP | Jun 21, 1988 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 089650 | — | Jun 21, 1988 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 089651 | AP | Jun 21, 1988 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 089644 | AP | Jun 21, 1988 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 089646 | — | Jun 21, 1988 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 088571 | AP | Sep 13, 1985 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE×2 | BELMORA LLC | ANDA 080504 | — | Oct 19, 1983 | |
| LIDOCATON | PHARMATON | ANDA 084729 | — | Aug 17, 1983 | |
| LIDOCATON | PHARMATON | ANDA 084728 | — | Aug 17, 1983 | |
| ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE | CARLISLE | ANDA 084720 | — | Approved Prior to Jan 1, 1982 | |
| ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE | CARLISLE | ANDA 084732 | — | Approved Prior to Jan 1, 1982 | |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINERLD×2 | WEST-WARD PHARMS INT | ANDA 080406 | — | Approved Prior to Jan 1, 1982 | |
| LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE | ABBOTT | ANDA 083154 | — | Approved Prior to Jan 1, 1982 | |
| LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE | BEL MAR | ANDA 080820 | — | Approved Prior to Jan 1, 1982 | |
| LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE | BEL MAR | ANDA 080757 | — | Approved Prior to Jan 1, 1982 | |
| LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE | DELL LABS | ANDA 083389 | — | Approved Prior to Jan 1, 1982 | |
| LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE | DELL LABS | ANDA 083390 | — | Approved Prior to Jan 1, 1982 | |
| LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE | INTL MEDICATION | ANDA 086402 | — | Approved Prior to Jan 1, 1982 | |
| LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE×2 | WATSON LABS | ANDA 080377 | — | Approved Prior to Jan 1, 1982 | |
| LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE | WATSON LABS | ANDA 085463 | — | Approved Prior to Jan 1, 1982 | |
| OCTOCAINE×2 | SEPTODONT | ANDA 084048 | — | 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.
Epinephrine; lidocaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
