Details for New Drug Application (NDA): 091579
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NDA 091579 describes EFAVIRENZ, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Strides Pharma, Hetero Labs Ltd V, Laurus, and Teva Pharms Usa, and is included in twenty-one NDAs. It is available from eight suppliers. Additional details are available on the EFAVIRENZ profile page.
The generic ingredient in EFAVIRENZ 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 EFAVIRENZ 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 091579
| Tradename: | EFAVIRENZ |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | efavirenz |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091579
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EFAVIRENZ | efavirenz | TABLET;ORAL | 091579 | ANDA | Macleods Pharmaceuticals Limited | 33342-013 | 33342-013-07 | 30 TABLET in 1 BOTTLE (33342-013-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | May 10, 2024 | TE: | AB | RLD: | No | ||||
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