Details for New Drug Application (NDA): 204806
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NDA 204806 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 four suppliers. Additional details are available on the ATAZANAVIR SULFATE profile page.
The generic ingredient in ATAZANAVIR SULFATE is atazanavir sulfate. There is one drug master file entry for this compound. Five 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 is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.
Summary for 204806
| Tradename: | ATAZANAVIR SULFATE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | atazanavir sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204806
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATAZANAVIR SULFATE | atazanavir sulfate | CAPSULE;ORAL | 204806 | ANDA | Aurobindo Pharma Limited | 65862-710 | 65862-710-03 | 3 BLISTER PACK in 1 CARTON (65862-710-03) / 10 CAPSULE in 1 BLISTER PACK (65862-710-10) |
| ATAZANAVIR SULFATE | atazanavir sulfate | CAPSULE;ORAL | 204806 | ANDA | Aurobindo Pharma Limited | 65862-710 | 65862-710-05 | 500 CAPSULE in 1 BOTTLE (65862-710-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jun 25, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jun 25, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jun 25, 2018 | TE: | AB | RLD: | No | ||||
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