Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086402
Company: INTL MEDICATION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.01MG/ML;1% 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
02/04/1980 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
09/19/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/15/1993 SUPPL-19 Labeling

Label is not available on this site.

01/14/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/29/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/17/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/30/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/08/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/08/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/13/1991 SUPPL-11 Labeling

Label is not available on this site.

04/21/1988 SUPPL-10 Labeling

Label is not available on this site.

04/27/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/27/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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