Details for New Drug Application (NDA): 021402
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NDA 021402 describes SYNTHROID, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. Additional details are available on the SYNTHROID profile page.
The generic ingredient in SYNTHROID 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 SYNTHROID 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 021402
| Tradename: | SYNTHROID |
| Applicant: | Abbvie |
| Ingredient: | levothyroxine sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021402
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYNTHROID | levothyroxine sodium | TABLET;ORAL | 021402 | NDA | AbbVie Inc. | 0074-3727 | 0074-3727-19 | 1000 TABLET in 1 BOTTLE (0074-3727-19) |
| SYNTHROID | levothyroxine sodium | TABLET;ORAL | 021402 | NDA | AbbVie Inc. | 0074-3727 | 0074-3727-72 | 2 BLISTER PACK in 1 CARTON (0074-3727-72) / 7 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: | Jul 24, 2002 | TE: | AB1,AB2 | 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: | Jul 24, 2002 | TE: | AB1,AB2 | 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: | Jul 24, 2002 | TE: | AB1,AB2 | RLD: | Yes | ||||
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