Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088191
Company: WOCKHARDT BIO AG

• Other Important Information from FDA

Products on ANDA 088191

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LINDANE	LINDANE	1%	SHAMPOO;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088191

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.