Details for New Drug Application (NDA): 206977
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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 three patents protecting this drug. Additional details are available on the TIROSINT-SOL profile page.
The generic ingredient in TIROSINT-SOL 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 TIROSINT-SOL 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 206977
| Tradename: | TIROSINT-SOL |
| Applicant: | Ibsa |
| Ingredient: | levothyroxine sodium |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
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 | 71858-0105-1 | 2 POUCH in 1 CARTON (71858-0105-1) / 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: | ⤷ Try a Trial | Patent Expiration: | Feb 28, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 28, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | 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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