Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203411
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEVIRAPINE | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 04/03/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203411Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/25/2022 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2019 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2019 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
NEVIRAPINE
TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NEVIRAPINE | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206879 | MACLEODS PHARMS LTD |
| NEVIRAPINE | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205651 | MYLAN |
| NEVIRAPINE | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203411 | SANDOZ |
| VIRAMUNE XR | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 201152 | BOEHRINGER INGELHEIM |