Details for New Drug Application (NDA): 021137
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NDA 021137 describes LEVOLET, which is a drug marketed by Genus Lifesciences and is included in one NDA. There are two patents protecting this drug. Additional details are available on the LEVOLET profile page.
The generic ingredient in LEVOLET 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.
The generic ingredient in LEVOLET 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 021137
| Tradename: | LEVOLET |
| Applicant: | Genus Lifesciences |
| Ingredient: | levothyroxine sodium |
| Patents: | 2 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | ||||
| Approval Date: | Jun 6, 2003 | TE: | AB1,AB2,AB3,AB4 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | ||||
| Approval Date: | Jun 6, 2003 | TE: | AB1,AB2,AB3,AB4 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | ||||
| Approval Date: | Jun 6, 2003 | TE: | AB1,AB2,AB3,AB4 | RLD: | No | ||||
| Patent: | 10,231,931 | Patent Expiration: | Mar 23, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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