Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 081318
Company: G AND W LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% JELLY;TOPICAL 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
04/29/1993 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
12/06/2005 SUPPL-19 Labeling

Label is not available on this site.

02/14/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/2002 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

01/23/2002 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

02/26/2001 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

03/23/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/23/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/15/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/07/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/24/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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