Application 091498
- Type
- ANDA
- Sponsor
- CSPC OUYI PHARM CO
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45865-357 | Tramadol Hydrochloride | Tramadol Hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 50090-4716 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-4717 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50436-0136 | TRAMADOL HYDROCHLORIDE | Tramadol Hydrochloride | Unit Dose Services | ANDA | Current |
| 53002-4321 | Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-4321 | Tramadol Hydrochloride | Tramadol Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-412 | TRAMADOL HYDROCHLORIDE | Tramadol hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-412 | TRAMADOL HYDROCHLORIDE | Tramadol hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 61786-487 | TRAMADOL HYDROCHLORIDE | Tramadol hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 67046-887 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1329 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 68071-4154 | TRAMADOL HYDROCHLORIDE | Tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4154 | TRAMADOL HYDROCHLORIDE | Tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4154 | TRAMADOL HYDROCHLORIDE | Tramadol hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 69543-136 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Virtus Pharmaceuticals LLC | ANDA | Current |
| 69543-136 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Virtus Pharmaceuticals LLC | ANDA | Current |
| 69543-136 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Virtus Pharmaceuticals LLC | ANDA | Current |
| 69543-136 | Tramadol Hydrochloride | Tramadol Hydrochloride | Virtus Pharmaceuticals LLC | ANDA | Current |
| 71205-389 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-389 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-389 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-389 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71335-1498 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71610-398 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 76420-127 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Asclemed USA, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76320 | ORIG | 2023-11-03 |