Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080377
Company: WATSON LABS

Products on ANDA 080377

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Discontinued	None	No	No
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Discontinued	None	No	No
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;1%	INJECTABLE;INJECTION	Discontinued	None	No	No
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;2%	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080377

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/20/1974	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
02/19/1999	SUPPL-264	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/10/1998	SUPPL-262	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/18/1998	SUPPL-260	Labeling		Label is not available on this site.
02/11/1997	SUPPL-259	Manufacturing (CMC)		Label is not available on this site.
12/04/1996	SUPPL-258	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
01/09/1997	SUPPL-257	Labeling		Label is not available on this site.
04/17/1995	SUPPL-256	Manufacturing (CMC)		Label is not available on this site.
04/19/1994	SUPPL-255	Manufacturing (CMC)		Label is not available on this site.
03/18/1991	SUPPL-254	Labeling		Label is not available on this site.
09/13/1991	SUPPL-253	Manufacturing (CMC)		Label is not available on this site.
06/06/1990	SUPPL-252	Labeling		Label is not available on this site.
07/03/1989	SUPPL-251	Bioequivalence		Label is not available on this site.
05/05/1989	SUPPL-249	Manufacturing (CMC)		Label is not available on this site.
07/17/1986	SUPPL-244	Manufacturing (CMC)		Label is not available on this site.
08/15/1986	SUPPL-243	Manufacturing (CMC)		Label is not available on this site.
01/23/1984	SUPPL-242	Manufacturing (CMC)		Label is not available on this site.
01/23/1984	SUPPL-240	Manufacturing (CMC)		Label is not available on this site.
05/27/1982	SUPPL-239	Manufacturing (CMC)		Label is not available on this site.
04/30/1982	SUPPL-238	Manufacturing (CMC)		Label is not available on this site.