Details for New Drug Application (NDA): 091673
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NDA 091673 describes ATAZANAVIR SULFATE, which is a drug marketed by Amneal, Aurobindo Pharma, Cipla, Hetero Labs Ltd Iii, Laurus, Mylan, Teva Pharms Usa, and Zydus Pharms, and is included in eight NDAs. It is available from five suppliers. Additional details are available on the ATAZANAVIR SULFATE profile page.
The generic ingredient in ATAZANAVIR SULFATE is atazanavir sulfate. There are twenty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.
The generic ingredient in ATAZANAVIR SULFATE is atazanavir sulfate. There are twenty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.
Summary for 091673
| Tradename: | ATAZANAVIR SULFATE |
| Applicant: | Teva Pharms Usa |
| Ingredient: | atazanavir sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091673
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATAZANAVIR SULFATE | atazanavir sulfate | CAPSULE;ORAL | 091673 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5526 | 0093-5526-06 | 60 CAPSULE in 1 BOTTLE (0093-5526-06) |
| ATAZANAVIR SULFATE | atazanavir sulfate | CAPSULE;ORAL | 091673 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5527 | 0093-5527-06 | 60 CAPSULE in 1 BOTTLE (0093-5527-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Apr 22, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Apr 22, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Apr 22, 2014 | TE: | AB | RLD: | No | ||||
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