Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087313
Company: OLTA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LINDANE LINDANE 1% LOTION;TOPICAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/17/1981 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
09/04/2001 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2001 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/17/1999 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/16/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/24/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/17/1996 SUPPL-29 Labeling

Label is not available on this site.

08/02/1994 SUPPL-28 Labeling

Label is not available on this site.

01/12/1993 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/30/1992 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/15/1991 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/04/1993 SUPPL-22 Labeling

Label is not available on this site.

09/28/1990 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/13/1990 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/02/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/15/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/15/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/30/1988 SUPPL-14 Labeling

Label is not available on this site.

07/08/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/18/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/09/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/09/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/01/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/03/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/25/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/25/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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