Drugs@FDA: FDA Approved Drug Products

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

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

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 090097 MAYNE PHARMA INC
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET;ORAL Prescription No AB 200295 SIGMAPHARM LABS LLC

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 090097 MAYNE PHARMA INC
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET;ORAL Prescription No AB 200295 SIGMAPHARM LABS LLC

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 090097 MAYNE PHARMA INC
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET;ORAL Prescription No AB 200295 SIGMAPHARM LABS LLC

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