Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083914
Company: HOSPIRA

Products on ANDA 083914

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%	LIDOCAINE HYDROCHLORIDE	5%	INJECTABLE;SPINAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083914

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/1974	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
11/02/2018	SUPPL-40	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
04/08/2010	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
02/24/1997	SUPPL-24	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/03/1996	SUPPL-23	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/24/1996	SUPPL-22	Labeling		Label is not available on this site.
11/02/1995	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
08/07/1989	SUPPL-19	Labeling		Label is not available on this site.
06/13/1989	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
12/20/1988	SUPPL-17	Labeling		Label is not available on this site.
08/09/1985	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/18/1984	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/23/1982	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/22/1982	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/22/1982	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.