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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200295
Company: SIGMAPHARM LABS LLC

Products on ANDA 200295

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET;ORAL	Prescription	AB	No	No
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET;ORAL	Prescription	AB	No	No
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200295

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200295

LIOTHYRONINE SODIUM

TABLET;ORAL; EQ 0.005MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYTOMEL	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET;ORAL	Prescription	Yes	AB	010379	KING PHARMS
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET;ORAL	Prescription	No	AB	218070	BIOCON PHARMA
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET;ORAL	Prescription	No	AB	090097	DR REDDYS LABS SA
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET;ORAL	Prescription	No	AB	200295	SIGMAPHARM LABS LLC
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET;ORAL	Prescription	No	AB	091382	SUN PHARM
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET;ORAL	Prescription	No	AB	211510	TEVA PHARMS USA
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET;ORAL	Prescription	No	AB	214803	ZYDUS

TABLET;ORAL; EQ 0.025MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYTOMEL	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET;ORAL	Prescription	Yes	AB	010379	KING PHARMS
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET;ORAL	Prescription	No	AB	218070	BIOCON PHARMA
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET;ORAL	Prescription	No	AB	090097	DR REDDYS LABS SA
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET;ORAL	Prescription	No	AB	200295	SIGMAPHARM LABS LLC
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET;ORAL	Prescription	No	AB	091382	SUN PHARM
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET;ORAL	Prescription	No	AB	211510	TEVA PHARMS USA
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET;ORAL	Prescription	No	AB	214803	ZYDUS

TABLET;ORAL; EQ 0.05MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYTOMEL	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET;ORAL	Prescription	Yes	AB	010379	KING PHARMS
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET;ORAL	Prescription	No	AB	218070	BIOCON PHARMA
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET;ORAL	Prescription	No	AB	090097	DR REDDYS LABS SA
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET;ORAL	Prescription	No	AB	200295	SIGMAPHARM LABS LLC
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET;ORAL	Prescription	No	AB	091382	SUN PHARM
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET;ORAL	Prescription	No	AB	211510	TEVA PHARMS USA
LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET;ORAL	Prescription	No	AB	214803	ZYDUS

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