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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088325
Company: HOSPIRA

Products on ANDA 088325

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088325

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/1984	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-38	Labeling-Package Insert		Label is not available on this site.
03/19/2020	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
04/16/2010	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
02/23/2005	SUPPL-14	Labeling		Label is not available on this site.
05/05/1998	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/03/1996	SUPPL-10	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
01/16/1997	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/10/1990	SUPPL-6	Labeling		Label is not available on this site.
12/19/1988	SUPPL-5	Labeling		Label is not available on this site.
10/14/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/01/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/01/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/17/1985	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088325

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

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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