Carbocaine W/ Neo-Cobefrin, Carbocaine

NDA 12125, held by Eastman Kodak. Levonordefrin; Mepivacaine Hydrochloride, Mepivacaine Hydrochloride.

As of Nov 13, 2026, NDA 12125 (Carbocaine W/ Neo-Cobefrin, Carbocaine), held by Eastman Kodak, was first approved by FDA on Jan 6, 1960, with 22 approved supplements and 0 published complete response letters.

First approved: Jan 6, 1960
Review: Priority
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jan 6, 1960	Original applicationNew combination · Priority review	Approved	None posted

Products

2 strengths and forms


Carbocaine W/ Neo-Cobefrin0.05MG/ML;2% · injectable;injection	Levonordefrin; Mepivacaine Hydrochloride	Discontinued
Carbocaine3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Mepivacaine Hydrochloride	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Mar 4, 1992	Supplement 34Labeling · Priority review	Approved	None posted
Aug 8, 1991	Supplement 33Labeling · Priority review	Approved	None posted
Jun 18, 1991	Supplement 32Manufacturing · Priority review	Approved	None posted
Jan 14, 1987	Supplement 31Manufacturing · Priority review	Approved	None posted
Jun 18, 1986	Supplement 30Labeling · Priority review	Approved	None posted
Mar 15, 1985	Supplement 29Manufacturing · Priority review	Approved	None posted
Oct 25, 1984	Supplement 26Labeling · Priority review	Approved	None posted
Mar 16, 1984	Supplement 28Manufacturing · Priority review	Approved	None posted
Sep 29, 1983	Supplement 27Manufacturing · Priority review	Approved	None posted
Jan 27, 1982	Supplement 25Manufacturing · Priority review	Approved	None posted
Dec 22, 1981	Supplement 23Labeling · Priority review	Approved	None posted
Aug 21, 1981	Supplement 24Manufacturing · Priority review	Approved	None posted
Jun 10, 1980	Supplement 21Labeling · Priority review	Approved	None posted
Dec 3, 1979	Supplement 17Labeling · Priority review	Approved	None posted
Jul 6, 1979	Supplement 20Labeling · Priority review	Approved	None posted
Jul 6, 1979	Supplement 19Manufacturing · Priority review	Approved	None posted
Mar 12, 1979	Supplement 18Manufacturing · Priority review	Approved	None posted
Mar 6, 1979	Supplement 12Manufacturing · Priority review	Approved	None posted
Jan 17, 1979	Supplement 16Labeling · Priority review	Approved	None posted
Aug 18, 1978	Supplement 14Manufacturing · Priority review	Approved	None posted
May 2, 1978	Supplement 11Labeling · Priority review	Approved	None posted
Jul 25, 1974	Supplement 8Labeling · Priority review	Approved	None posted
Jan 6, 1960	Original applicationNew combination · Priority review	Approved	None posted

Identifiers

Application: NDA 12125
Drugs@FDA: Overview at FDA
Company: Eastman Kodak Company

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters