Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087266
Company: OLTA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LINDANE LINDANE 1% SHAMPOO;TOPICAL Prescription AT 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
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
04/05/2004 SUPPL-23 Labeling

Label is not available on this site.

10/09/2001 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/29/2000 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/29/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1996 SUPPL-17 Labeling

Label is not available on this site.

08/02/1994 SUPPL-16 Labeling

Label is not available on this site.

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

Label is not available on this site.

09/28/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/04/1992 SUPPL-13 Labeling

Label is not available on this site.

02/03/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/26/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/07/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

LINDANE

SHAMPOO;TOPICAL; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LINDANE LINDANE 1% SHAMPOO;TOPICAL Prescription No AT 087266 OLTA PHARMS
LINDANE LINDANE 1% SHAMPOO;TOPICAL Prescription No AT 088191 WOCKHARDT

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