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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070554
Company: FRESENIUS KABI USA

Products on ANDA 070554

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070554

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/1986	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
11/02/2022	SUPPL-37	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/01/2015	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
05/17/2010	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
03/08/2002	SUPPL-19	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/08/2001	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
05/21/2001	SUPPL-17	Labeling		Label is not available on this site.
08/25/1997	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
05/31/1996	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/26/1996	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/11/1992	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/10/1993	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/12/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/18/1990	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/03/1991	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/03/1991	SUPPL-5	Labeling		Label is not available on this site.
11/10/1987	SUPPL-4	Labeling		Label is not available on this site.
10/14/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/14/1987	SUPPL-2	Labeling		Label is not available on this site.
10/14/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 070554

SENSORCAINE

INJECTABLE;INJECTION; 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;INJECTION	Prescription	No	AP	070585	HOSPIRA
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	No	AP	203895	EUGIA PHARMA
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	No	AP	204842	HIKMA PHARMS
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	No	AP	091487	STERISCIENCE
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	Yes	AP	016964	HOSPIRA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	Yes	AP	018304	FRESENIUS KABI USA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	No	AP	070554	FRESENIUS KABI USA

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