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Generated: July 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210632

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NDA 210632 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-two suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 210632
Tradename:LEVOTHYROXINE SODIUM
Applicant:Fresenius Kabi Usa
Ingredient:levothyroxine sodium
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 210632
Suppliers and Packaging for NDA: 210632
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632 NDA Fresenius Kabi USA, LLC 63323-885 63323-885-10 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-885-10) > 5 mL in 1 VIAL, SINGLE-DOSE
LEVOTHYROXINE SODIUM levothyroxine sodium SOLUTION;INTRAVENOUS 210632 NDA Fresenius Kabi USA, LLC 63323-890 63323-890-10 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-890-10) > 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength100MCG/5ML (20MCG/ML)
Approval Date:Apr 11, 2019TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 1, 2036Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength200MCG/5ML (40MCG/ML)
Approval Date:Apr 11, 2019TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 1, 2036Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength500MCG/5ML (100MCG/ML)
Approval Date:Apr 11, 2019TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 1, 2036Product Flag?YSubstance Flag?Delist Request?

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