Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208475
Company: B BRAUN MEDICAL

Products on ANDA 208475

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 208475

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/08/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/01/2026	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208475

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