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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206163
Company: PIRAMAL CRITICAL

Products on ANDA 206163

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206163

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206163ORig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206163Orig1s000ltr.pdf

Labels for ANDA 206163

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/29/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206163ORig1s000lbl.pdf

Therapeutic Equivalents for ANDA 206163

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	217495	XIROMED
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/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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