Details for New Drug Application (NDA): 021116
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NDA 021116 describes THYRO-TABS, which is a drug marketed by Alvogen and is included in one NDA. It is available from eleven suppliers. Additional details are available on the THYRO-TABS profile page.
The generic ingredient in THYRO-TABS 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 THYRO-TABS 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 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of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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of Special Situations, Levothyroxine Sodium **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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