Application 091677
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOPINAVIR; RITONAVIR | LOPINAVIR; RITONAVIR | TABLET; ORAL | 200MG; 50MG | No | No |
| 002 | LOPINAVIR AND RITONAVIR | LOPINAVIR; RITONAVIR | TABLET;ORAL | 200MG;50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-556 | Lopinavir and ritonavir | Lopinavir and ritonavir | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-603 | Lopinavir and ritonavir | Lopinavir and ritonavir | Camber Pharmaceuticals, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31545 | ORIG | 2012-05-24 |