Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084697
Company: SEPTODONT INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN 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
02/06/1976 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/02/1999 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

04/19/1993 SUPPL-21 Labeling

Label is not available on this site.

04/13/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/26/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/13/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/07/1992 SUPPL-17 Labeling

Label is not available on this site.

09/12/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/13/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/11/1984 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/11/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/09/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/09/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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