Drugs@FDA: FDA-Approved Drugs
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 |
| EFAVIRENZ | EFAVIRENZ | 600MG | TABLET;ORAL | Prescription | No | AB | 204869 | STRIDES PHARMA |
| SUSTIVA | EFAVIRENZ | 600MG | TABLET;ORAL | Prescription | Yes | AB | 021360 | BRISTOL MYERS SQUIBB |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English