Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074133
Company: HOSPIRA
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
12/21/1993 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
01/30/2016 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

02/27/2013 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

03/11/2010 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

11/04/2008 SUPPL-17 Labeling

Label is not available on this site.

04/28/2008 SUPPL-16 Labeling

Label is not available on this site.

09/19/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/03/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/14/2001 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/22/1995 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/01/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-1 Manufacturing (CMC)

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 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
METOPROLOL TARTRATE METOPROLOL TARTRATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 076495 WEST-WARD PHARMS INT

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