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 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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