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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211369
Company: TEVA PHARMS USA INC

Products on ANDA 211369

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG	CAPSULE;ORAL	Discontinued	None	No	No
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG	CAPSULE;ORAL	Discontinued	None	No	No
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG	CAPSULE;ORAL	Discontinued	None	No	No
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE;ORAL	Prescription	AB	No	No
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE;ORAL	Prescription	AB	No	No
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211369

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211369Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/02/2023	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211369

LEVOTHYROXINE SODIUM

CAPSULE;ORAL; 0.2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE;ORAL	Prescription	No	AB	211369	TEVA PHARMS USA INC
TIROSINT	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE;ORAL	Prescription	Yes	AB	021924	INSTITUT BIOCHIMIQUE

CAPSULE;ORAL; 0.137MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE;ORAL	Prescription	No	AB	211369	TEVA PHARMS USA INC
TIROSINT	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE;ORAL	Prescription	Yes	AB	021924	INSTITUT BIOCHIMIQUE

CAPSULE;ORAL; 0.175MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE;ORAL	Prescription	No	AB	211369	TEVA PHARMS USA INC
TIROSINT	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE;ORAL	Prescription	Yes	AB	021924	INSTITUT BIOCHIMIQUE

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