Details for New Drug Application (NDA): 021292
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NDA 021292 describes EUTHYROX, which is a drug marketed by Provell and is included in one NDA. It is available from one supplier. Additional details are available on the EUTHYROX profile page.
The generic ingredient in EUTHYROX is levothyroxine sodium. There are ten drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
The generic ingredient in EUTHYROX is levothyroxine sodium. There are ten drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 021292
| Tradename: | EUTHYROX |
| Applicant: | Provell |
| Ingredient: | levothyroxine sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021292
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EUTHYROX | levothyroxine sodium | TABLET;ORAL | 021292 | NDA | Provell Pharmaceuticals, LLC | 72305-025 | 72305-025-30 | 2 BLISTER PACK in 1 CARTON (72305-025-30) / 15 TABLET in 1 BLISTER PACK |
| EUTHYROX | levothyroxine sodium | TABLET;ORAL | 021292 | NDA | Provell Pharmaceuticals, LLC | 72305-025 | 72305-025-90 | 6 BLISTER PACK in 1 CARTON (72305-025-90) / 15 TABLET in 1 BLISTER PACK |
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: | May 31, 2002 | TE: | AB2 | 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: | May 31, 2002 | TE: | AB2 | 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: | May 31, 2002 | TE: | AB2 | RLD: | No | ||||
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