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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088328
Company: HOSPIRA

Products on ANDA 088328

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088328

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/1984	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
03/19/2020	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
03/19/2020	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
04/16/2010	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
10/03/1996	SUPPL-8	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/22/1996	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/10/1990	SUPPL-4	Labeling		Label is not available on this site.
12/12/1988	SUPPL-3	Labeling		Label is not available on this site.
08/15/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/18/1985	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088328

LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION; 0.5%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	088328	HOSPIRA
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	088325	HOSPIRA
XYLOCAINE	LIDOCAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	Yes	AP	006488	FRESENIUS KABI USA

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