Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202231
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER;INTRAVENOUS Prescription AP Yes Yes
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER;INTRAVENOUS Prescription AP Yes Yes
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER;INTRAVENOUS 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
06/24/2011 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202231s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202231s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202231_levothyroxine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202231Orig1s000Sum.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/04/2014 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/26/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/16/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/20/2012 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202231s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202231Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2012 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202231s003lbl.pdf
06/24/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202231s000lbl.pdf

LEVOTHYROXINE SODIUM

POWDER;INTRAVENOUS; 100MCG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER;INTRAVENOUS Prescription No AP 208837 DR REDDYS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 202231 FRESENIUS KABI USA
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER;INTRAVENOUS Prescription No AP 208749 MAIA PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER;INTRAVENOUS Prescription No AP 206163 PIRAMAL CRITICAL

POWDER;INTRAVENOUS; 200MCG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 202231 FRESENIUS KABI USA
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER;INTRAVENOUS Prescription No AP 208749 MAIA PHARMS INC

POWDER;INTRAVENOUS; 500MCG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 202231 FRESENIUS KABI USA
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER;INTRAVENOUS Prescription No AP 208749 MAIA PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER;INTRAVENOUS Prescription No AP 206163 PIRAMAL CRITICAL

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