FDA Orange Book · active-ingredient family
Bupivacaine hydrochloride; epinephrine
Bupivacaine hydrochloride; epinephrine is approved in 7 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 071165 | — | Jun 16, 1988 | |
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 071166 | — | Jun 16, 1988 | |
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 071167 | — | Jun 16, 1988 | |
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 071168 | AP | Jun 16, 1988 | |
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 071169 | — | Jun 16, 1988 | |
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 071170 | AP | Jun 16, 1988 | |
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | HOSPIRA | ANDA 071171 | — | Jun 16, 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.
Bupivacaine hydrochloride; epinephrine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
