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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202231
Company: FRESENIUS KABI USA

Summary Review

Products on NDA 202231

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202231

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

Labels for NDA 202231

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

Therapeutic Equivalents for NDA 202231

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	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
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	217066	ZYDUS PHARMS

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
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	217066	ZYDUS PHARMS

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
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	217066	ZYDUS PHARMS

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