Details for New Drug Application (NDA): 021924
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NDA 021924 describes TIROSINT, which is a drug marketed by Institut Biochimique and is included in two NDAs. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TIROSINT profile page.
The generic ingredient in TIROSINT is levothyroxine sodium. There are ten drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
The generic ingredient in TIROSINT is levothyroxine sodium. There are ten drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 021924
| Tradename: | TIROSINT |
| Applicant: | Institut Biochimique |
| Ingredient: | levothyroxine sodium |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021924
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924 | NDA AUTHORIZED GENERIC | Lannett Company, Inc. | 0527-4951 | 0527-4951-32 | 3 BLISTER PACK in 1 CARTON (0527-4951-32) / 10 CAPSULE in 1 BLISTER PACK |
| TIROSINT | levothyroxine sodium | CAPSULE;ORAL | 021924 | NDA AUTHORIZED GENERIC | Lannett Company, Inc. | 0527-4952 | 0527-4952-32 | 3 BLISTER PACK in 1 CARTON (0527-4952-32) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.025MG | ||||
| Approval Date: | Oct 13, 2006 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 14, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 14, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.05MG | ||||
| Approval Date: | Oct 13, 2006 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 14, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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