Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076887
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TERBUTALINE SULFATE TERBUTALINE SULFATE 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
05/26/2004 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
10/21/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/08/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

TERBUTALINE SULFATE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TERBUTALINE SULFATE TERBUTALINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 078151 AKORN
TERBUTALINE SULFATE TERBUTALINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 076770 ATHENEX INC
TERBUTALINE SULFATE TERBUTALINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 076887 FRESENIUS KABI USA
TERBUTALINE SULFATE TERBUTALINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 078630 HIKMA FARMACEUTICA
TERBUTALINE SULFATE TERBUTALINE SULFATE 1MG/ML INJECTABLE;INJECTION Prescription No AP 200122 UNITED BIOMEDCL

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