Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083198
Company: LUITPOLD

Products on ANDA 083198

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083198

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/1972	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
04/09/2010	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
02/26/2010	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
10/31/2000	SUPPL-19	Labeling		Label is not available on this site.
09/02/1997	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/05/1997	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
03/05/1997	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
03/05/1997	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/24/1993	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/20/1991	SUPPL-13	Labeling		Label is not available on this site.
04/06/1992	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/06/1992	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
09/20/1988	SUPPL-10	Labeling		Label is not available on this site.
02/16/1989	SUPPL-9	Labeling		Label is not available on this site.
06/09/1986	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
06/09/1986	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/14/1982	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.