Drugs@FDA: FDA Approved Drug Products

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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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