Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211242
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/04/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

NOREPINEPHRINE BITARTRATE

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 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 040455 TEVA PHARMS USA
NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 040462 WEST-WARD PHARMS INT

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