Details for New Drug Application (NDA): 022142
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NDA 022142 describes SYMFI, which is a drug marketed by Mylan Labs Ltd and Mylan and is included in two NDAs. It is available from one supplier. Additional details are available on the SYMFI profile page.
The generic ingredient in SYMFI 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 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 022142
| Tradename: | SYMFI |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | efavirenz; lamivudine; tenofovir disoproxil fumarate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 022142
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYMFI | efavirenz; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 022142 | NDA | Mylan Specialty L.P. | 49502-475 | 49502-475-93 | 1 BOTTLE, PLASTIC in 1 CARTON (49502-475-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG;300MG;300MG | ||||
| Approval Date: | Mar 22, 2018 | TE: | AB | RLD: | Yes | ||||
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