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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089645
Company: HOSPIRA

Products on ANDA 089645

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1.5%	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089645

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/1988	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
07/15/2020	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
07/15/2020	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
04/12/2010	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/03/2002	SUPPL-8	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
01/02/2002	SUPPL-7	Labeling		Label is not available on this site.
05/26/1998	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/26/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/26/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/09/1990	SUPPL-3	Labeling		Label is not available on this site.
03/21/1990	SUPPL-2	Labeling		Label is not available on this site.
07/06/1989	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 089645

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

INJECTABLE;INJECTION; 0.005MG/ML;1.5%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1.5%	INJECTABLE;INJECTION	Prescription	No	AP	208475	B BRAUN MEDICAL INC
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1.5%	INJECTABLE;INJECTION	Prescription	No	AP	088571	HOSPIRA
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1.5%	INJECTABLE;INJECTION	Prescription	No	AP	089645	HOSPIRA
XYLOCAINE W/ EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.005MG/ML;1.5%	INJECTABLE;INJECTION	Prescription	Yes	AP	006488	FRESENIUS KABI USA

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