Details for New Drug Application (NDA): 215809
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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: | 9,345,772 | Patent Expiration: | Feb 27, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
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