Application 202075
- Type
- ANDA
- Sponsor
- ACI HEALTHCARE LTD
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 |
| 002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69150-020 | Tramadol Hydrochloride | Tramadol Hydrochloride | BIOMES PHARMACEUTICALS LLC | ANDA | Current |
| 71093-119 | tramadol hydrochloride | tramadol hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-119 | tramadol hydrochloride | tramadol hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-119 | tramadol hydrochloride | tramadol hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76444 | ORIG | 2023-11-07 |