Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077521
Company: AUROBINDO
Company: AUROBINDO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEVIRAPINE | NEVIRAPINE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/22/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077521ta_ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/31/2023 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/10/2019 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/10/2019 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/01/2013 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
NEVIRAPINE
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NEVIRAPINE | NEVIRAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 077521 | AUROBINDO |
| NEVIRAPINE | NEVIRAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 077956 | CIPLA |
| NEVIRAPINE | NEVIRAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 078584 | HETERO LABS LTD III |
| NEVIRAPINE | NEVIRAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 090688 | MACLEODS PHARMS LTD |
| NEVIRAPINE | NEVIRAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 203080 | MICRO LABS LTD |
| NEVIRAPINE | NEVIRAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 202523 | MYLAN PHARMS INC |
| NEVIRAPINE | NEVIRAPINE | 200MG | TABLET;ORAL | Prescription | No | AB | 078195 | STRIDES PHARMA |