Application 078886
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EFAVIRENZ | EFAVIRENZ | TABLET;ORAL | 600MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-504 | Efavirenz | Efavirenz | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-504 | Efavirenz | Efavirenz | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 72865-172 | EFAVIRENZ | EFAVIRENZ | XLCare Pharmaceuticals Inc. | ANDA | Current |
| 72865-172 | EFAVIRENZ | EFAVIRENZ | XLCare Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31396 | ORIG | 2008-03-04 |