Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209087
Company: B BRAUN MEDICAL

Products on ANDA 209087

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;SPINAL	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209087

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/2019	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
10/25/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209087

BUPIVACAINE HYDROCHLORIDE

INJECTABLE;SPINAL; 0.75%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;SPINAL	Prescription	No	AP	209087	B BRAUN MEDICAL
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;SPINAL	Prescription	No	AP	071810	HOSPIRA
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;SPINAL	Prescription	No	AP	212822	HUONS
MARCAINE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;SPINAL	Prescription	Yes	AP	018692	HOSPIRA