Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204621
Company: ALVOGEN
Company: ALVOGEN
| 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 |
| NEVIRAPINE | NEVIRAPINE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/11/2015 | ORIG-2 | Approval |
Label is not available on this site. |
||||
| 07/10/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204621Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/14/2019 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/14/2019 | SUPPL-4 | 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 | 204621 | ALVOGEN |
| NEVIRAPINE | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207698 | AUROBINDO PHARMA LTD |
| 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 INC |
| VIRAMUNE XR | NEVIRAPINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 201152 | BOEHRINGER INGELHEIM |
TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NEVIRAPINE | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204621 | ALVOGEN |
| NEVIRAPINE | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208616 | AUROBINDO PHARMA LTD |
| VIRAMUNE XR | NEVIRAPINE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 201152 | BOEHRINGER INGELHEIM |
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