Application 040893
- Type
- ANDA
- Sponsor
- ANDA REPOSITORY
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 002 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No |
| 003 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 004 | MEPERIDINE HYDROCHLORIDE | MEPERIDINE HYDROCHLORIDE | TABLET;ORAL | 150MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46672-829 | meperidine hydrochloride | meperidine hydrochloride | Mikart, LLC | ANDA | Current |
| 46672-829 | meperidine hydrochloride | meperidine hydrochloride | Mikart, LLC | ANDA | Current |
| 46672-830 | meperidine hydrochloride | meperidine hydrochloride | Mikart, LLC | ANDA | Current |
| 46672-830 | meperidine hydrochloride | meperidine hydrochloride | Mikart, LLC | ANDA | Current |
| 46672-831 | meperidine hydrochloride | meperidine hydrochloride | Mikart, LLC | ANDA | Current |
| 46672-831 | meperidine hydrochloride | meperidine hydrochloride | Mikart, LLC | ANDA | Current |
| 46672-832 | meperidine hydrochloride | meperidine hydrochloride | Mikart, LLC | ANDA | Current |
| 46672-832 | meperidine hydrochloride | meperidine hydrochloride | Mikart, LLC | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 76119 | ORIG | 2023-11-03 |