Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088390
Company: DEPROCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIGNOSPAN STANDARD EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE EQ 0.01MG BASE/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
01/22/1985 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
07/28/2017 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

06/29/2007 SUPPL-35 Labeling

Label is not available on this site.

10/04/2004 SUPPL-31 Labeling

Label is not available on this site.

04/06/2000 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/2000 SUPPL-24 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/04/1996 SUPPL-21 Labeling

Label is not available on this site.

08/04/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/23/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/09/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/12/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/03/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/27/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/05/1988 SUPPL-9 Labeling

Label is not available on this site.

06/08/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/16/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/14/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

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