Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080850
Company: LUITPOLD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 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
06/23/1972 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
04/09/2010 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

02/26/2010 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

10/31/2000 SUPPL-22 Labeling

Label is not available on this site.

08/03/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/03/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/03/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/24/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/11/1991 SUPPL-17 Labeling

Label is not available on this site.

04/06/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/06/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/14/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/14/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/21/1982 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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