Application 090371
- Type
- ANDA
- Sponsor
- CIPLA LIMITED
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 |
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 2 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69097-561 | Lopinavir and Ritonavir | Lopinavir and Ritonavir | Cipla USA Inc. | ANDA | Current |
| 69097-562 | Lopinavir and Ritonavir | Lopinavir and Ritonavir | Cipla USA Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9267 | ORIG | 2009-11-24 |