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Generated: April 27, 2017

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Details for New Drug Application (NDA): 021301

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NDA 021301 describes LEVOXYL, which is a drug marketed by King Pharms R And D and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug. Additional details are available on the LEVOXYL profile page.

The generic ingredient in LEVOXYL is levothyroxine sodium. There are ten drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for NDA: 021301

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021301


Suppliers and Packaging for NDA: 021301

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
levothyroxine sodium
TABLET;ORAL 021301 NDA Physicians Total Care, Inc. 54868-3849 54868-3849-1 30 TABLET in 1 BOTTLE (54868-3849-1)
levothyroxine sodium
TABLET;ORAL 021301 NDA Physicians Total Care, Inc. 54868-4087 54868-4087-1 30 TABLET in 1 BOTTLE (54868-4087-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:May 25, 2001TE:AB1,AB3RLD:Yes
Patent:6,555,581Patent Expiration:Feb 15, 2022Product Flag?Substance Flag?Delist Request?
Patent:7,067,148Patent Expiration:Feb 15, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:7,101,569Patent Expiration:Oct 2, 2023Product Flag?Substance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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