Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 204869
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EFAVIRENZ | EFAVIRENZ | 600MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 03/12/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
EFAVIRENZ
TABLET;ORAL; 600MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EFAVIRENZ | EFAVIRENZ | 600MG | TABLET;ORAL | Prescription | No | AB | 077673 | AUROBINDO PHARMA LTD |
| EFAVIRENZ | EFAVIRENZ | 600MG | TABLET;ORAL | Prescription | No | AB | 205322 | AUROBINDO PHARMA LTD |
| EFAVIRENZ | EFAVIRENZ | 600MG | TABLET;ORAL | Prescription | No | AB | 204766 | CIPLA |
| EFAVIRENZ | EFAVIRENZ | 600MG | TABLET;ORAL | Prescription | No | AB | 078886 | HETERO LABS LTD III |
| EFAVIRENZ | EFAVIRENZ | 600MG | TABLET;ORAL | Prescription | No | AB | 091471 | MYLAN PHARMS INC |
| EFAVIRENZ | EFAVIRENZ | 600MG | TABLET;ORAL | Prescription | No | AB | 204869 | STRIDES PHARMA |
| SUSTIVA | EFAVIRENZ | 600MG | TABLET;ORAL | Prescription | Yes | AB | 021360 | BRISTOL MYERS SQUIBB |
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