Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091673
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
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 |
---|---|---|---|---|---|---|---|
04/22/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/091673Orig1s000ltr.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 |
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 |
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 |
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 |
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 |