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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208749
Company: MAIA PHARMS INC

Products on ANDA 208749

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	200MCG/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 208749

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208749

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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