Details for New Drug Application (NDA): 078886
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NDA 078886 describes EFAVIRENZ, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Norvium Bioscience, Strides Pharma, Hetero Labs Ltd V, Laurus, Teva Pharms Usa, and Chartwell Rx, and is included in twenty-one NDAs. It is available from five 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 078886
| Tradename: | EFAVIRENZ |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | efavirenz |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078886
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EFAVIRENZ | efavirenz | TABLET;ORAL | 078886 | ANDA | Camber Pharmaceuticals, Inc. | 31722-504 | 31722-504-25 | 250 TABLET, FILM COATED in 1 BOTTLE (31722-504-25) |
| EFAVIRENZ | efavirenz | TABLET;ORAL | 078886 | ANDA | Camber Pharmaceuticals, Inc. | 31722-504 | 31722-504-30 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-504-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Apr 27, 2018 | TE: | AB | RLD: | No | ||||
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