Application 083365
- Type
- ANDA
- Sponsor
- HIKMA INTL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCORTISONE | HYDROCORTISONE | TABLET;ORAL | 20MG | No | No |
| 002 | HYDROCORTISONE | HYDROCORTISONE | TABLET;ORAL | 5MG | No | No |
| 003 | HYDROCORTISONE | HYDROCORTISONE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-1252 | Hydrocortisone | Hydrocortisone | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-1253 | Hydrocortisone | Hydrocortisone | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-1254 | Hydrocortisone | Hydrocortisone | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0904-2674 | Hydrocortisone | Hydrocortisone | Major Pharmaceuticals | ANDA | Current |
| 43063-386 | Hydrocortisone | Hydrocortisone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |