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Application 012911
- Type
- NDA
- Sponsor
- HRA PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METOPIRONE | METYRAPONE | TABLET;ORAL | 250MG | No | No |
| 002 | METOPIRONE | METYRAPONE | CAPSULE;ORAL | 250MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 76336-455 | Metopirone | Metyrapone | HRA Pharma Rare Diseases | NDA | Current |
| 76336-455 | Metopirone | Metyrapone | Laboratoire HRA Pharma | NDA | Current |
| 76336-455 | Metopirone | Metyrapone | HRA Pharma Rare Diseases | NDA | Current |
| 76336-455 | Metopirone | Metyrapone | HRA Pharma Rare Diseases | NDA | Current |
| 76336-455 | Metopirone | Metyrapone | HRA Pharma Rare Diseases | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 74900 | SUPPL | 2023-07-27 |
| 74898 | SUPPL | 2023-07-26 |
| 72059 | SUPPL | 2022-09-10 |
| 72055 | SUPPL | 2022-09-09 |
| 61987 | SUPPL | 2020-02-27 |
| 61928 | SUPPL | 2020-02-21 |
| 56092 | SUPPL | 2018-10-24 |
| 56084 | SUPPL | 2018-10-23 |
| 10827 | SUPPL | 2014-03-04 |
| 348 | SUPPL | 2014-03-04 |
| 12041 | SUPPL | 2010-11-08 |
| 10826 | SUPPL | 2010-11-04 |
| 347 | SUPPL | 2004-05-07 |