Application 005010
- Type
- NDA
- Sponsor
- US PHARM HOLDINGS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEMEROL | MEPERIDINE HYDROCHLORIDE | TABLET;ORAL | 50MG | Yes | No |
| 002 | DEMEROL | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No |
| 003 | DEMEROL | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/ML | No | No |
| 004 | DEMEROL | MEPERIDINE HYDROCHLORIDE | TABLET;ORAL | 100MG | Yes | No |
| 005 | DEMEROL | MEPERIDINE HYDROCHLORIDE | SYRUP;ORAL | 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 007 | DEMEROL | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML | No | No |
| 009 | DEMEROL | MEPERIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 75MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 30698-335 | Demerol | Meperidine Hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-335 | Demerol | Meperidine Hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-335 | Demerol | Meperidine Hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-335 | Demerol | Meperidine Hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-337 | Demerol | Meperidine Hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-337 | Demerol | Meperidine Hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-337 | Demerol | Meperidine Hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-337 | Demerol | Meperidine Hydrochloride | Validus Pharmaceuticals LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84695 | SUPPL | 2026-01-06 |
| 84694 | SUPPL | 2026-01-06 |
| 84548 | SUPPL | 2025-12-29 |
| 80067 | SUPPL | 2024-11-04 |
| 76875 | SUPPL | 2023-12-18 |
| 76222 | ORIG | 2023-11-03 |
| 66524 | SUPPL | 2021-03-05 |
| 66523 | SUPPL | 2021-03-05 |
| 66510 | SUPPL | 2021-03-05 |
| 60295 | SUPPL | 2019-10-08 |
| 60293 | SUPPL | 2019-10-08 |
| 60292 | SUPPL | 2019-10-08 |
| 55841 | SUPPL | 2018-10-05 |
| 55839 | SUPPL | 2018-10-05 |
| 55838 | SUPPL | 2018-10-05 |
| 55645 | SUPPL | 2018-09-28 |
| 55644 | SUPPL | 2018-09-28 |
| 49572 | SUPPL | 2017-08-29 |
| 49449 | SUPPL | 2017-08-17 |
| 46420 | SUPPL | 2016-12-21 |
| 46194 | SUPPL | 2016-12-19 |
| 59 | SUPPL | 2011-11-02 |
| 10676 | SUPPL | 2011-10-31 |
| 13 | SUPPL | 2011-04-13 |
| 10675 | SUPPL | 2011-04-11 |
| 10674 | SUPPL | 2009-03-17 |
| 12 | SUPPL | 2009-03-10 |
| 58 | SUPPL | 2003-06-08 |
| 11 | SUPPL | 2003-03-10 |