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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 007513
Company: HOSPIRA
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
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-Package Insert, Labeling-Container/Carton Labels 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.

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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007513Orig1s024lbl.pdf
09/26/2007 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007513Orig1s024lbl.pdf

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 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 211242 MYLAN LABS LTD
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 211359 SANDOZ INC
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 211980 SUN PHARM
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 040455 TEVA PHARMS USA
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 216341 ZYDUS PHARMS
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