Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080925
Company: SEPTODONT INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOCAINE HYDROCHLORIDE MEPIVACAINE HYDROCHLORIDE 3% 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
10/17/1972 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-23 Manufacturing (CMC)-Facility

Label is not available on this site.

04/19/1993 SUPPL-22 Labeling

Label is not available on this site.

03/11/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/26/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/11/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/05/1992 SUPPL-17 Labeling

Label is not available on this site.

09/20/1990 SUPPL-16 Labeling

Label is not available on this site.

05/16/1991 SUPPL-14 Labeling

Label is not available on this site.

05/16/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/07/1983 SUPPL-12 Labeling

Label is not available on this site.

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

Label is not available on this site.

06/16/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/25/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/09/1982 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/13/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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