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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012250
Company: HOSPIRA

Products on NDA 012250

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	1.5%	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012250

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/1960	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2023	SUPPL-40	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/012250s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/012250Orig1s040ltr.pdf
11/02/2018	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012250s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012250Orig1s037Ltr.pdf
02/19/2010	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012250s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012250s033ltr.pdf
09/28/2005	SUPPL-28	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012250s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/012250s028ltr.pdf
01/31/2001	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
03/11/1999	SUPPL-22	Labeling		Label is not available on this site.
05/21/1991	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/27/1999	SUPPL-19	Labeling		Label is not available on this site.
03/15/1985	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
03/30/1984	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/29/1987	SUPPL-16	Labeling		Label is not available on this site.
08/21/1981	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
10/03/1980	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
06/15/1978	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/26/1979	SUPPL-12	Labeling		Label is not available on this site.
10/06/1976	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/28/1975	SUPPL-8	Labeling		Label is not available on this site.
04/15/1974	SUPPL-7	Labeling		Label is not available on this site.

Labels for NDA 012250

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2023	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/012250s040lbl.pdf
11/02/2018	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012250s037lbl.pdf
02/19/2010	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012250s033lbl.pdf
09/28/2005	SUPPL-28	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012250s028lbl.pdf

Therapeutic Equivalents for NDA 012250

CARBOCAINE

INJECTABLE;INJECTION; 1%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	Yes	AP	012250	HOSPIRA
POLOCAINE	MEPIVACAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	089407	FRESENIUS KABI USA
POLOCAINE-MPF	MEPIVACAINE HYDROCHLORIDE	1%	INJECTABLE;INJECTION	Prescription	No	AP	089406	FRESENIUS KABI USA

INJECTABLE;INJECTION; 2%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	Yes	AP	012250	HOSPIRA
POLOCAINE	MEPIVACAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	089410	FRESENIUS KABI USA
POLOCAINE-MPF	MEPIVACAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	089409	FRESENIUS KABI USA

INJECTABLE;INJECTION; 1.5%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	1.5%	INJECTABLE;INJECTION	Prescription	Yes	AP	012250	HOSPIRA
POLOCAINE-MPF	MEPIVACAINE HYDROCHLORIDE	1.5%	INJECTABLE;INJECTION	Prescription	No	AP	089408	FRESENIUS KABI USA

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