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Generated: September 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202231

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NDA 202231 describes LEVOTHYROXINE SODIUM, which is a drug marketed by Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Amneal Pharms Llc, Lupin Atlantis, Merck Kgaa, and Mylan, and is included in nine NDAs. It is available from sixteen suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LEVOTHYROXINE SODIUM profile page.

The generic ingredient in LEVOTHYROXINE SODIUM is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 202231
Tradename:LEVOTHYROXINE SODIUM
Applicant:Fresenius Kabi Usa
Ingredient:levothyroxine sodium
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 202231
Suppliers and Packaging for NDA: 202231
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 202231 NDA Par Pharmaceutical Inc. 42023-201 42023-201-01 1 VIAL, SINGLE-DOSE in 1 CARTON (42023-201-01) > 5 mL in 1 VIAL, SINGLE-DOSE
LEVOTHYROXINE SODIUM levothyroxine sodium POWDER;INTRAVENOUS 202231 NDA Par Pharmaceutical Inc. 42023-202 42023-202-01 1 VIAL, SINGLE-DOSE in 1 CARTON (42023-202-01) > 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength100MCG/VIAL
Approval Date:Jun 24, 2011TE:APRLD:Yes
Patent:  Try a Free TrialPatent Expiration:Oct 3, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:  Try a Free TrialPatent Expiration:Aug 29, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:  Try a Free TrialPatent Expiration:Aug 29, 2032Product Flag?YSubstance 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.