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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 202231


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NDA 202231 describes LEVOTHYROXINE SODIUM, which is a drug marketed by Teva Pharms Usa Inc, Dr Reddys, Endo Operations, Fresenius Kabi Usa, Maia Pharms Inc, Piramal Critical, Zydus Pharms, Hikma, Accord Hlthcare, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms Ltd, Merck Kgaa, Mylan, and Watson Labs Teva, and is included in nineteen NDAs. It is available from thirty-six suppliers. There are seven 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-one 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
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:⤷  Sign UpPatent Expiration:Oct 3, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Aug 29, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Aug 29, 2032Product Flag?YSubstance Flag?Delist Request?

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