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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018053
Company: HOSPIRA

Products on NDA 018053

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Discontinued	None	No	No
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE;INJECTION	Discontinued	None	No	No
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018053

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/1978	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
03/09/2021	SUPPL-61	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018053s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018053Orig1s061ltr.pdf
11/02/2018	SUPPL-60	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018053s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018053Orig1s60Ltr.pdf
01/11/2016	SUPPL-57	Manufacturing (CMC)		Label is not available on this site.
05/06/2014	SUPPL-56	Manufacturing (CMC)		Label is not available on this site.
07/10/2015	SUPPL-55	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018053s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018053Orig1s055ltr.pdf
04/07/2010	SUPPL-52	Labeling-Package Insert		Label is not available on this site.
08/29/2002	SUPPL-44	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
11/02/1999	SUPPL-43	Labeling		Label is not available on this site.
04/07/1999	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
02/24/1997	SUPPL-40	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
11/04/1996	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
11/04/1996	SUPPL-38	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/11/1991	SUPPL-36	Labeling		Label is not available on this site.
01/29/1992	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
05/04/1990	SUPPL-34	Labeling		Label is not available on this site.
02/15/1991	SUPPL-33	Labeling		Label is not available on this site.
04/07/1988	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018053

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2021	SUPPL-61	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018053s061lbl.pdf
11/02/2018	SUPPL-60	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018053s060lbl.pdf
07/10/2015	SUPPL-55	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018053s055lbl.pdf

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