Application 075666
- Type
- ANDA
- Sponsor
- PERRIGO ISRAEL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | CREAM;TOPICAL | 0.2% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45802-455 | Hydrocortisone Valerate | Hydrocortisone Valerate | Perrigo New York Inc | ANDA | Current |
| 45802-455 | Hydrocortisone Valerate | Hydrocortisone Valerate | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-455 | Hydrocortisone Valerate | Hydrocortisone Valerate | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 50090-2525 | Hydrocortisone Valerate | Hydrocortisone Valerate | A-S Medication Solutions | ANDA | Current |
| 61919-010 | HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | DIRECT RX | ANDA | Current |
| 61919-010 | HYDROCORTISONE VALERATE | HYDROCORTISONE VALERATE | DIRECT RX | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30983 | ORIG | 2000-05-24 |