Application 078064
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EFAVIRENZ | EFAVIRENZ | CAPSULE;ORAL | 50MG | No | No |
| 002 | EFAVIRENZ | EFAVIRENZ | CAPSULE;ORAL | 100MG | No | No |
| 003 | EFAVIRENZ | EFAVIRENZ | CAPSULE;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 64980-406 | Efavirenz | Efavirenz | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-406 | Efavirenz | Efavirenz | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-406 | Efavirenz | Efavirenz | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-406 | Efavirenz | Efavirenz | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-406 | Efavirenz | Efavirenz | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-407 | Efavirenz | Efavirenz | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-407 | Efavirenz | Efavirenz | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-407 | Efavirenz | Efavirenz | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-407 | Efavirenz | Efavirenz | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-407 | Efavirenz | Efavirenz | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 65862-104 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-104 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-104 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-104 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-104 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-105 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-105 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-105 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-105 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-105 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-106 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-106 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-106 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-106 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
| 65862-106 | Efavirenz | Efavirenz | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9112 | ORIG | 2006-12-28 |