Details for New Drug Application (NDA): 021210
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The generic ingredient in UNITHROID is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 021210
| Tradename: | UNITHROID |
| Applicant: | Stevens J |
| Ingredient: | levothyroxine sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021210
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| UNITHROID | levothyroxine sodium | TABLET;ORAL | 021210 | NDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8573 | 0615-8573-14 | 14 TABLET in 1 BLISTER PACK (0615-8573-14) |
| UNITHROID | levothyroxine sodium | TABLET;ORAL | 021210 | NDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8573 | 0615-8573-39 | 30 TABLET in 1 BLISTER PACK (0615-8573-39) |
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: | Aug 21, 2000 | TE: | AB1,AB2,AB3 | RLD: | Yes | ||||
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: | Aug 21, 2000 | TE: | AB1,AB2,AB3 | RLD: | Yes | ||||
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: | Aug 21, 2000 | TE: | AB1,AB2,AB3 | RLD: | Yes | ||||
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