Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088388
Company: DEPROCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SCANDONEST L LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE 0.05MG/ML;2% INJECTABLE;INJECTION Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/10/1984 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
11/02/2018 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

09/12/2008 SUPPL-30 Labeling

Label is not available on this site.

06/18/2007 SUPPL-29 Labeling

Label is not available on this site.

10/12/2004 SUPPL-27 Labeling

Label is not available on this site.

04/06/2000 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/2000 SUPPL-19 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/04/1996 SUPPL-16 Labeling

Label is not available on this site.

08/04/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/16/1993 SUPPL-14 Labeling

Label is not available on this site.

05/12/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/07/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/05/1988 SUPPL-8 Labeling

Label is not available on this site.

06/22/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/08/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/14/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/16/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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