Details for New Drug Application (NDA): 214253
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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 214253
Tradename: | LEVOTHYROXINE SODIUM |
Applicant: | Hikma |
Ingredient: | levothyroxine sodium |
Patents: | 1 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214253
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOTHYROXINE SODIUM | levothyroxine sodium | SOLUTION;INTRAVENOUS | 214253 | NDA | Hikma Pharmaceuticals USA Inc. | 24201-002 | 24201-002-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (24201-002-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MCG/ML | ||||
Approval Date: | May 17, 2021 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 20, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? |
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