Application 204621
- Type
- ANDA
- Sponsor
- ALVOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEVIRAPINE | NEVIRAPINE | TABLET, EXTENDED RELEASE;ORAL | 400MG | No | No |
| 002 | NEVIRAPINE | NEVIRAPINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47781-317 | Nevirapine Extended Release | nevirapine | Alvogen Inc. | ANDA | Current |
| 47781-317 | Nevirapine Extended Release | nevirapine | Alvogen Inc. | ANDA | Current |
| 47781-317 | Nevirapine Extended Release | nevirapine | Alvogen Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10363 | ORIG | 2015-11-17 |