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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086578
Company: ACTAVIS MID ATLANTIC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE VISCOUS LIDOCAINE HYDROCHLORIDE 2% SOLUTION;ORAL 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
05/09/1980 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
11/02/2018 SUPPL-40 Labeling-Package Insert

Label is not available on this site.
12/01/2014 SUPPL-39 Labeling-Package Insert

Label is not available on this site.
10/30/2000 SUPPL-34 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
11/02/2000 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/03/2000 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.
10/03/2000 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.
06/27/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
04/05/1995 SUPPL-27 Labeling

Label is not available on this site.
10/11/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
10/11/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
04/06/1992 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
09/28/1990 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
06/03/1991 SUPPL-21 Labeling

Label is not available on this site.
10/25/1989 SUPPL-20 Labeling

Label is not available on this site.
01/14/1991 SUPPL-19 Labeling

Label is not available on this site.
05/09/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
01/15/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
01/22/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
01/22/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
06/09/1983 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
07/12/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
04/26/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
04/26/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
09/21/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
09/21/1982 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
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