Assyro AI

FDA Orange Book · active-ingredient family

Mepivacaine hydrochloride

Mepivacaine hydrochloride is approved as 2 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CARBOCAINE · NDA 012125

2

Brand (NDA)

14

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
CARBOCAINERLDEASTMAN KODAKNDA 012125—Approved Prior to Jan 1, 1982
CARBOCAINERLD×3HOSPIRANDA 012250—Approved Prior to Jan 1, 1982

Generic (ANDA) products (14)

ProductApplicantApplicationTEApproved
MEPIVACAINE HYDROCHLORIDEHOSPIRA INCANDA 040806—Apr 28, 2008
POLOCAINEFRESENIUS KABI USAANDA 089407—Dec 01, 1986
POLOCAINEFRESENIUS KABI USAANDA 089410—Dec 01, 1986
POLOCAINE-MPFFRESENIUS KABI USAANDA 089406—Dec 01, 1986
POLOCAINE-MPFFRESENIUS KABI USAANDA 089408—Dec 01, 1986
POLOCAINE-MPFFRESENIUS KABI USAANDA 089409—Dec 01, 1986
MEPIVACAINE HYDROCHLORIDEWATSON LABSANDA 088769—Nov 20, 1984
MEPIVACAINE HYDROCHLORIDEWATSON LABSANDA 088770—Nov 20, 1984
SCANDONEST PLAINDEPROCOANDA 088387—Oct 10, 1984
POLOCAINEDENTSPLY PHARMANDA 088653—Aug 21, 1984
MEPIVACAINE HYDROCHLORIDEINTL MEDICATION SYSANDA 087509—Oct 05, 1982
ARESTOCAINE HYDROCHLORIDESOLVAYANDA 084777—Apr 18, 1982
ISOCAINE HYDROCHLORIDESEPTODONTANDA 080925—Approved Prior to Jan 1, 1982
MEPIVACAINE HYDROCHLORIDEBELMORA LLCANDA 083559—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.

Mepivacaine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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