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Last Updated: October 11, 2024

Details for New Drug Application (NDA): 215259


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NDA 215259 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-three 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. Forty-eight suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 215259
Tradename:LEVOTHYROXINE SODIUM
Applicant:Ascent Pharms Inc
Ingredient:levothyroxine sodium
Patents:0
Pharmacology for NDA: 215259
Suppliers and Packaging for NDA: 215259
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 215259 ANDA Camber Pharmaceuticals, Inc. 31722-284 31722-284-01 100 TABLET in 1 BOTTLE (31722-284-01)
LEVOTHYROXINE SODIUM levothyroxine sodium TABLET;ORAL 215259 ANDA Camber Pharmaceuticals, Inc. 31722-284 31722-284-10 1000 TABLET in 1 BOTTLE (31722-284-10)

Profile 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:Jan 18, 2023TE:AB4RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:Jan 18, 2023TE:AB4RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:Jan 18, 2023TE:AB4RLD:No

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