Details for New Drug Application (NDA): 206977
NDA 206977 describes TIROSINT-SOL, which is a drug marketed by Ibsa and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the TIROSINT-SOL profile page.
The generic ingredient in TIROSINT-SOL 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 TIROSINT-SOL 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 206977
| Tradename: | TIROSINT-SOL |
| Applicant: | Ibsa |
| Ingredient: | levothyroxine sodium |
| Patents: | 4 |
Suppliers and Packaging for NDA: 206977
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977 | NDA | IBSA Pharma Inc. | 71858-0105 | 71858-0105-2 | 6 POUCH in 1 CARTON (71858-0105-2) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) |
| TIROSINT-SOL | levothyroxine sodium | SOLUTION;ORAL | 206977 | NDA | IBSA Pharma Inc. | 71858-0105 | 71858-0105-5 | 6 POUCH in 1 CARTON (71858-0105-5) / 5 AMPULE in 1 POUCH (71858-0105-4) / 1 mL in 1 AMPULE (71858-0105-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 13MCG/ML | ||||
| Approval Date: | Dec 15, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 10,537,538 | Patent Expiration: | Feb 28, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,096,913 | Patent Expiration: | Feb 28, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,241,382 | Patent Expiration: | Sep 17, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HYPOTHYROIDISM BY ORAL ADMINISTRATION OF L-THYROXINE TO A PATIENT ON AN EMPTY STOMACH 15 MINUTES BEFORE BREAKFAST | ||||||||
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