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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070967
Company: FRESENIUS KABI USA

Products on ANDA 070967

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.25%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070967

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/13/1987	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-33	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/01/2015	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
05/19/2010	SUPPL-19	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.
05/21/2001	SUPPL-14	Labeling		Label is not available on this site.
08/25/1997	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/14/1997	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.
05/13/1992	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/27/1991	SUPPL-4	Labeling		Label is not available on this site.
12/03/1991	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/03/1991	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/10/1987	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 070967

SENSORCAINE

INJECTABLE;INJECTION; 0.25%;0.0091MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.25%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016964	HOSPIRA
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.25%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016964	HOSPIRA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.25%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	070966	FRESENIUS KABI USA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.25%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	070967	FRESENIUS KABI USA

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