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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018692
Company: HOSPIRA

Products on NDA 018692

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MARCAINE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;SPINAL	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018692

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/1984	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018692Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2022	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018692s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018692Orig1s024ltr.pdf
11/02/2018	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018692s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018692Orig1s020ltr.pdf
09/19/2014	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/30/2012	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018692s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016964s070,018692s015,022046s004ltr.pdf
02/19/2010	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018692s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018692s014ltr.pdf
06/12/2003	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18692slr007ltr.pdf
08/21/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
03/09/1999	SUPPL-3	Labeling		Label is not available on this site.
03/09/1999	SUPPL-2	Labeling		Label is not available on this site.
06/26/1987	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018692

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2022	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018692s024lbl.pdf
11/02/2018	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018692s020lbl.pdf
01/30/2012	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018692s015lbl.pdf
02/19/2010	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018692s014lbl.pdf

Therapeutic Equivalents for NDA 018692

MARCAINE

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 INC
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

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