Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204806
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/25/2018 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204806Orig1s000TAltr.pdf |
ATAZANAVIR SULFATE
CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204806 | AUROBINDO PHARMA LTD |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 200626 | CIPLA |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091673 | TEVA PHARMS USA |
CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209717 | AMNEAL |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204806 | AUROBINDO PHARMA LTD |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 200626 | CIPLA |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212278 | HETERO LABS LTD III |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212579 | LAURUS |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091673 | TEVA PHARMS USA |
CAPSULE;ORAL; EQ 200MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209717 | AMNEAL |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204806 | AUROBINDO PHARMA LTD |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 200626 | CIPLA |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212278 | HETERO LABS LTD III |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212579 | LAURUS |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091673 | TEVA PHARMS USA |
| REYATAZ | ATAZANAVIR SULFATE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021567 | BRISTOL MYERS SQUIBB |
CAPSULE;ORAL; EQ 300MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209717 | AMNEAL |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204806 | AUROBINDO PHARMA LTD |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 200626 | CIPLA |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212278 | HETERO LABS LTD III |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212579 | LAURUS |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091673 | TEVA PHARMS USA |
| REYATAZ | ATAZANAVIR SULFATE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021567 | BRISTOL MYERS SQUIBB |
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