Details for New Drug Application (NDA): 208749
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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 208749
Tradename: | LEVOTHYROXINE SODIUM |
Applicant: | Maia Pharms Inc |
Ingredient: | levothyroxine sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 208749
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOTHYROXINE SODIUM | levothyroxine sodium | POWDER;INTRAVENOUS | 208749 | ANDA | Sagent Pharmaceuticals | 25021-468 | 25021-468-10 | 1 VIAL in 1 CARTON (25021-468-10) / 5 mL in 1 VIAL |
LEVOTHYROXINE SODIUM | levothyroxine sodium | POWDER;INTRAVENOUS | 208749 | ANDA | Sagent Pharmaceuticals | 25021-469 | 25021-469-10 | 1 VIAL in 1 CARTON (25021-469-10) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MCG/VIAL | ||||
Approval Date: | Dec 21, 2018 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 200MCG/VIAL | ||||
Approval Date: | Dec 21, 2018 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MCG/VIAL | ||||
Approval Date: | Dec 21, 2018 | TE: | AP | RLD: | No |
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