An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088571
Company: HOSPIRA

Products on ANDA 088571

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 088571

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/1985	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-30	Labeling-Package Insert		Label is not available on this site.
07/15/2020	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
04/09/2010	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
01/02/2002	SUPPL-7	Labeling		Label is not available on this site.
12/27/2002	SUPPL-6	Labeling		Label is not available on this site.
02/15/1991	SUPPL-5	Labeling		Label is not available on this site.
05/10/1989	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/07/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088571

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
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

Top