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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 007513
Company: HOSPIRA

Products on NDA 007513

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOPHED	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 007513

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/13/1950	ORIG-1	Approval	Type 1 - New Molecular Entity	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
10/21/2020	SUPPL-45	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/007513s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/007513Orig1s045ltr.pdf
06/15/2020	SUPPL-38	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/007513s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/007513Orig1s038ltr.pdf
09/26/2007	SUPPL-24	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007513Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007513s024ltr.pdf
09/20/1999	SUPPL-22	Labeling		Label is not available on this site.
09/13/1991	SUPPL-21	Labeling		Label is not available on this site.
06/12/1991	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
03/02/1988	SUPPL-19	Labeling		Label is not available on this site.
05/27/1987	SUPPL-18	Labeling		Label is not available on this site.
01/14/1985	SUPPL-17	Labeling		Label is not available on this site.
04/06/1989	SUPPL-16	Labeling		Label is not available on this site.
04/14/1978	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
02/14/1977	SUPPL-9	Unspecified		Label is not available on this site.

Labels for NDA 007513

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2020	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/007513s045lbl.pdf
06/15/2020	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/007513s038lbl.pdf
09/26/2007	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007513Orig1s024lbl.pdf
09/26/2007	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007513Orig1s024lbl.pdf

Therapeutic Equivalents for NDA 007513

LEVOPHED

INJECTABLE;INJECTION; EQ 1MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOPHED	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	007513	HOSPIRA
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	210839	AMNEAL
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	040859	BAXTER HLTHCARE CORP
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	214455	BRECKENRIDGE
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	217575	CAPLIN
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	211382	FRESENIUS KABI USA
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	214323	GLAND PHARMA LTD
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	040462	HIKMA
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	203662	HIKMA
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	040455	MEITHEAL
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	211242	MYLAN LABS LTD
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	211359	SANDOZ
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	211980	SUN PHARM

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