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Generated: November 17, 2018

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Details for New Drug Application (NDA): 010379

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NDA 010379 describes CYTOMEL, which is a drug marketed by King Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the CYTOMEL profile page.

The generic ingredient in CYTOMEL is liothyronine sodium. There are four drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the liothyronine sodium profile page.
Summary for 010379
Tradename:CYTOMEL
Applicant:King Pharms
Ingredient:liothyronine sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 010379
Ingredient-typeTriiodothyronine
Suppliers and Packaging for NDA: 010379
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYTOMEL liothyronine sodium TABLET;ORAL 010379 NDA Pfizer Laboratories Div Pfizer Inc 60793-115 60793-115-01 100 TABLET in 1 BOTTLE (60793-115-01)
CYTOMEL liothyronine sodium TABLET;ORAL 010379 NDA Pfizer Laboratories Div Pfizer Inc 60793-116 60793-116-01 100 TABLET in 1 BOTTLE (60793-116-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.005MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.025MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.05MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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