Application 008697
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CORTEF | HYDROCORTISONE | TABLET;ORAL | 10MG | Yes | No |
| 002 | CORTEF | HYDROCORTISONE | TABLET;ORAL | 20MG | Yes | Yes |
| 003 | CORTEF | HYDROCORTISONE | TABLET;ORAL | 5MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0009-0012 | CORTEF | hydrocortisone | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0012 | CORTEF | hydrocortisone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0012 | CORTEF | hydrocortisone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0031 | CORTEF | hydrocortisone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0031 | CORTEF | hydrocortisone | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0031 | CORTEF | hydrocortisone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0044 | CORTEF | hydrocortisone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0044 | CORTEF | hydrocortisone | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0044 | CORTEF | hydrocortisone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 59762-0073 | Hydrocortisone | hydrocortisone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0073 | Hydrocortisone | hydrocortisone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0073 | Hydrocortisone | hydrocortisone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0074 | Hydrocortisone | hydrocortisone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0074 | Hydrocortisone | hydrocortisone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0074 | Hydrocortisone | hydrocortisone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0075 | Hydrocortisone | hydrocortisone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0075 | Hydrocortisone | hydrocortisone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0075 | Hydrocortisone | hydrocortisone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 70518-3275 | CORTEF | hydrocortisone | REMEDYREPACK INC. | NDA | Current |
| 76420-028 | Hydrocortisone | hydrocortisone | Asclemed USA, Inc. | NDA AUTHORIZED GENERIC | Current |
| 76420-028 | Hydrocortisone | hydrocortisone | Asclemed USA, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78703 | SUPPL | 2024-06-07 |
| 78670 | SUPPL | 2024-06-06 |
| 77119 | SUPPL | 2023-12-22 |
| 77102 | SUPPL | 2023-12-21 |
| 61029 | SUPPL | 2019-11-22 |
| 61015 | SUPPL | 2019-11-22 |
| 45258 | SUPPL | 2016-09-09 |
| 45257 | SUPPL | 2016-09-09 |
| 45253 | SUPPL | 2016-09-09 |
| 45252 | SUPPL | 2016-09-09 |
| 32967 | SUPPL | 2015-04-15 |