Application 083082
- Type
- ANDA
- Sponsor
- HIKMA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | TABLET;ORAL | 250MG | No | No |
| 002 | CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-1195 | Chloroquine | Chloroquine Phosphate | West-ward Pharmaceutical Corp | ANDA | Current |
| 0143-2125 | Chloroquine | Chloroquine Phosphate | West-ward Pharmaceutical Corp | ANDA | Current |
| 55289-856 | Chloroquine | Chloroquine Phosphate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 68151-0487 | Chloroquine | Chloroquine Phosphate | Carilion Materials Management | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 39571 | SUPPL | 2009-11-16 |