Details for New Drug Application (NDA): 215809
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NDA 215809 describes ERMEZA, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ERMEZA profile page.
The generic ingredient in ERMEZA 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 ERMEZA 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 215809
| Tradename: | ERMEZA |
| Applicant: | Mylan |
| Ingredient: | levothyroxine sodium |
| Patents: | 1 |
Suppliers and Packaging for NDA: 215809
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERMEZA | levothyroxine sodium | SOLUTION;ORAL | 215809 | NDA | Mylan Specialty L.P. | 49502-378 | 49502-378-15 | 1 BOTTLE, GLASS in 1 CARTON (49502-378-15) / 150 mL in 1 BOTTLE, GLASS |
| ERMEZA | levothyroxine sodium | SOLUTION;ORAL | 215809 | NDA | Mylan Specialty L.P. | 49502-378 | 49502-378-75 | 1 BOTTLE, GLASS in 1 CARTON (49502-378-75) / 75 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 150MCG/5ML | ||||
| Approval Date: | Apr 29, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 27, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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