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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010379
Company: KING PHARMS

Products on NDA 010379

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010379

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/1956	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/21/2020	SUPPL-57	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010379Orig1s057ltr.pdf
12/21/2018	SUPPL-54	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010379s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/010379Orig1s054Ltr.pdf
05/17/2002	SUPPL-47	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10379s47lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10379S047ltr.pdf
02/27/2002	SUPPL-46	Manufacturing (CMC)-Control		Label is not available on this site.
09/13/2001	SUPPL-45	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10379s45ltr.pdf
04/14/2001	SUPPL-44	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
07/18/2000	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
11/16/2000	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
06/02/1994	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
03/17/1995	SUPPL-40	Labeling		Label is not available on this site.
03/28/1994	SUPPL-39	Labeling		Label is not available on this site.
08/06/1990	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
02/19/1986	SUPPL-37	Labeling		Label is not available on this site.
03/07/1984	SUPPL-36	Labeling		Label is not available on this site.
03/07/1984	SUPPL-34	Labeling		Label is not available on this site.
06/16/1975	SUPPL-14	Labeling		Label is not available on this site.

Labels for NDA 010379

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2018	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010379s054lbl.pdf
05/17/2002	SUPPL-47	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10379s47lbl.pdf

Therapeutic Equivalents for NDA 010379

CYTOMEL

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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