Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088191
Company: WOCKHARDT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LINDANE LINDANE 1% SHAMPOO;TOPICAL Prescription AT 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
09/18/1984 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
08/22/2007 SUPPL-25 Labeling

Label is not available on this site.

03/27/1997 SUPPL-22 Labeling

Label is not available on this site.

06/28/1995 SUPPL-21 Labeling

Label is not available on this site.

08/02/1994 SUPPL-20 Labeling

Label is not available on this site.

10/24/1989 SUPPL-18 Labeling

Label is not available on this site.

02/22/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/10/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/24/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/24/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/18/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/18/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/24/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/23/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/23/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/23/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/23/1984 SUPPL-1 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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