Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 018304
Company: FRESENIUS KABI USA

Products on NDA 018304

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Prescription	AP	Yes	No
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	AP	Yes	No
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	AP	Yes	No
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.5%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	No
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.75%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018304

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1981	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
07/19/2022	SUPPL-50	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018304s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018304Orig1s050ltr.pdf
11/02/2018	SUPPL-49	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018304s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018304Orig1s049Ltr.pdf
07/10/2015	SUPPL-45	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018304Orig1s044,s045ltr.pdf
07/10/2015	SUPPL-44	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018304Orig1s044,s045ltr.pdf
01/29/2016	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
05/17/2010	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
12/23/2002	SUPPL-33	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/08/2002	SUPPL-32	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/08/2001	SUPPL-31	Manufacturing (CMC)-Control		Label is not available on this site.
06/01/2001	SUPPL-30	Labeling		Label is not available on this site.
07/30/1999	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
04/14/1997	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
05/31/1996	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
10/14/1997	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
12/27/1994	SUPPL-23	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/11/1992	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
03/10/1993	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
05/08/1992	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
11/08/1991	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/27/1991	SUPPL-16	Labeling		Label is not available on this site.
08/01/1989	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/01/1989	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/27/1989	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/27/1991	SUPPL-12	Labeling		Label is not available on this site.
05/11/1988	SUPPL-11	Labeling		Label is not available on this site.
09/24/1987	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018304

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
07/19/2022	SUPPL-50	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018304s050lbl.pdf
11/02/2018	SUPPL-49	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018304s049lbl.pdf
07/10/2015	SUPPL-45	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf
07/10/2015	SUPPL-45	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf
07/10/2015	SUPPL-44	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf

Therapeutic Equivalents for NDA 018304

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	220493	ANTHEA PHARMA
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

INJECTABLE;INJECTION; 0.5%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	220493	ANTHEA PHARMA
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	217821	ASPIRO
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	207183	EUGIA PHARMA
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	205141	HIKMA PHARMS
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	070584	HOSPIRA
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	070597	HOSPIRA
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	070609	HOSPIRA
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	216039	MEITHEAL
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	216040	MEITHEAL
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	091503	ONESOURCE SPECIALTY
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	217792	SOMERSET
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	203895	EUGIA PHARMA
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	204842	HIKMA PHARMS
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	091487	ONESOURCE SPECIALTY
MARCAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	Yes	AP	016964	HOSPIRA
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	Yes	AP	016964	HOSPIRA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	Yes	AP	018304	FRESENIUS KABI USA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	070553	FRESENIUS KABI USA

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	220493	ANTHEA PHARMA
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	No	AP	217821	ASPIRO
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	No	AP	070585	HOSPIRA
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	No	AP	216040	MEITHEAL
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	ONESOURCE SPECIALTY
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

INJECTABLE;INJECTION; 0.5%;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	0.5%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016964	HOSPIRA
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.5%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016964	HOSPIRA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.5%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018304	FRESENIUS KABI USA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.5%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	070968	FRESENIUS KABI USA

INJECTABLE;INJECTION; 0.75%;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 PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.75%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016964	HOSPIRA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.75%;0.0091MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018304	FRESENIUS KABI USA