Details for New Drug Application (NDA): 208255
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NDA 208255 describes SYMFI LO, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. Additional details are available on the SYMFI LO profile page.
The generic ingredient in SYMFI LO is efavirenz; lamivudine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the efavirenz; lamivudine; tenofovir disoproxil fumarate profile page.
The generic ingredient in SYMFI LO is efavirenz; lamivudine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the efavirenz; lamivudine; tenofovir disoproxil fumarate profile page.
Summary for 208255
| Tradename: | SYMFI LO |
| Applicant: | Mylan |
| Ingredient: | efavirenz; lamivudine; tenofovir disoproxil fumarate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208255
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYMFI LO | efavirenz; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 208255 | NDA | Mylan Specialty L.P. | 49502-425 | 49502-425-93 | 1 BOTTLE, PLASTIC in 1 CARTON (49502-425-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG;300MG;300MG | ||||
| Approval Date: | Feb 5, 2018 | TE: | AB | RLD: | Yes | ||||
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