Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012125
Company: EASTMAN KODAK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBOCAINE MEPIVACAINE HYDROCHLORIDE 3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CARBOCAINE W/ NEO-COBEFRIN LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE 0.05MG/ML;2% INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/06/1960 ORIG-1 Approval Type 4 - New Combination PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/1992 SUPPL-34 Labeling

Label is not available on this site.

08/08/1991 SUPPL-33 Labeling

Label is not available on this site.

06/18/1991 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/14/1987 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1986 SUPPL-30 Labeling

Label is not available on this site.

03/15/1985 SUPPL-29 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/16/1984 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/29/1983 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/1984 SUPPL-26 Labeling

Label is not available on this site.

01/27/1982 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1981 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1981 SUPPL-23 Labeling

Label is not available on this site.

06/10/1980 SUPPL-21 Labeling

Label is not available on this site.

07/06/1979 SUPPL-20 Labeling

Label is not available on this site.

07/06/1979 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/12/1979 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1979 SUPPL-17 Labeling

Label is not available on this site.

01/17/1979 SUPPL-16 Labeling

Label is not available on this site.

08/18/1978 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1979 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/02/1978 SUPPL-11 Labeling

Label is not available on this site.

07/25/1974 SUPPL-8 Labeling

Label is not available on this site.

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