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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091045
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/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
10/25/2010 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
09/15/2021 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

08/13/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

METOPROLOL TARTRATE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 078950 BAXTER HLTHCARE CORP
METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 091045 FRESENIUS KABI USA
METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 204205 GLAND PHARMA LTD
METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 076495 HIKMA
METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 077761 HIKMA FARMACEUTICA
METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 074133 HOSPIRA
METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 075160 HOSPIRA
METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 078085 HOSPIRA
METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 077360 SANDOZ INC
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