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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 202231


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NDA 202231 describes LEVOTHYROXINE SODIUM, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Amneal Pharms Llc, Lupin Atlantis, Merck Kgaa, and Mylan, and is included in ten NDAs. It is available from fourteen suppliers. There are five 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. Thirty-eight 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
Paragraph IV (Patent) Challenges for 202231
Tradename Dosage Ingredient NDA Submissiondate
LEVOTHYROXINE SODIUM POWDER;INTRAVENOUS levothyroxine sodium 202231 2015-05-01
LEVOTHYROXINE SODIUM POWDER;INTRAVENOUS levothyroxine sodium 202231 2015-04-14

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

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