Details for New Drug Application (NDA): 021116
NDA 021116 describes THYRO-TABS, which is a drug marketed by Alvogen and is included in one NDA. It is available from ten suppliers. Additional details are available on the THYRO-TABS profile page.
The generic ingredient in THYRO-TABS 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 THYRO-TABS 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 021116
| Tradename: | THYRO-TABS |
| Applicant: | Alvogen |
| Ingredient: | levothyroxine sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021116
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THYRO-TABS | levothyroxine sodium | TABLET;ORAL | 021116 | NDA | Alvogen, Inc. | 47781-640 | 47781-640-10 | 1000 TABLET in 1 BOTTLE (47781-640-10) |
| THYRO-TABS | levothyroxine sodium | TABLET;ORAL | 021116 | NDA | Alvogen, Inc. | 47781-640 | 47781-640-90 | 90 TABLET in 1 BOTTLE (47781-640-90) |
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of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 24, 2002 | TE: | AB1,AB2,AB3,AB4 | 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of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 24, 2002 | TE: | AB1,AB2,AB3,AB4 | 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of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 24, 2002 | TE: | AB1,AB2,AB3,AB4 | RLD: | Yes | ||||
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