Details for New Drug Application (NDA): 021210
NDA 021210 describes UNITHROID, which is a drug marketed by Stevens J and is included in one NDA. It is available from five suppliers. Additional details are available on the UNITHROID profile page.
The generic ingredient in UNITHROID is levothyroxine sodium. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
The generic ingredient in UNITHROID is levothyroxine sodium. There is one drug master file entry for this compound. Fifty 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 | 0615-8573-05 | 15 TABLET in 1 BLISTER PACK (0615-8573-05) |
| 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) |
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 | ||||
Complete Access Available with Subscription
