Details for New Drug Application (NDA): 212278
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NDA 212278 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 212278
| Tradename: | ATAZANAVIR SULFATE |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | atazanavir sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212278
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATAZANAVIR SULFATE | atazanavir sulfate | CAPSULE;ORAL | 212278 | ANDA | Camber Pharmaceuticals, Inc. | 31722-653 | 31722-653-10 | 1000 CAPSULE in 1 BOTTLE (31722-653-10) |
| ATAZANAVIR SULFATE | atazanavir sulfate | CAPSULE;ORAL | 212278 | ANDA | Camber Pharmaceuticals, Inc. | 31722-653 | 31722-653-31 | 100 BLISTER PACK in 1 CARTON (31722-653-31) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Feb 2, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Feb 2, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 300MG BASE | ||||
| Approval Date: | Feb 2, 2022 | TE: | AB | RLD: | No | ||||
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