Application 075172
- Type
- ANDA
- Sponsor
- PADDOCK LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COLOCORT | HYDROCORTISONE | ENEMA;RECTAL | 100MG/60ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0574-2020 | Colocort | Hydrocortisone | Paddock Laboratories, LLC | ANDA | Current |
| 62135-020 | Hydrocortisone Rectal Suspension (Retention) | Hydrocortisone | Chartwell RX, LLC | ANDA | Current |
| 62135-020 | Hydrocortisone Rectal Suspension (Retention) | Hydrocortisone | Chartwell RX LLC | ANDA | Current |
| 62135-020 | Hydrocortisone Rectal Suspension (Retention) | Hydrocortisone | Chartwell RX LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30781 | ORIG | 1999-12-06 |