Details for New Drug Application (NDA): 202231
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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 |
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: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MCG/VIAL | ||||
Approval Date: | Jun 24, 2011 | TE: | AP | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 3, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 29, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 29, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? |
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