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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070552
Company: FRESENIUS KABI USA

Products on ANDA 070552

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070552

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-30	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/01/2015	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
05/17/2010	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
03/08/2002	SUPPL-16	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/08/2001	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
09/07/2000	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
05/21/2001	SUPPL-13	Labeling		Label is not available on this site.
09/27/1996	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/31/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
09/11/1992	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/10/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/12/1992	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/18/1990	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/12/1989	SUPPL-3	Labeling		Label is not available on this site.
09/03/1991	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/03/1991	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 070552

SENSORCAINE

INJECTABLE;INJECTION; 0.25%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	217821	ASPIRO
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	207183	EUGIA PHARMA
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	205141	HIKMA PHARMS
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	070583	HOSPIRA
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	070590	HOSPIRA
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	216039	MEITHEAL
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	216040	MEITHEAL
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	091503	ONESOURCE SPECIALTY
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	217792	SOMERSET
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	203895	EUGIA PHARMA
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	204842	HIKMA PHARMS
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	091487	ONESOURCE SPECIALTY
MARCAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	Yes	AP	016964	HOSPIRA
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	Yes	AP	016964	HOSPIRA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	Yes	AP	018304	FRESENIUS KABI USA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	No	AP	070552	FRESENIUS KABI USA

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