Application 203494
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA 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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16571-716 | Tramadol Hydrochloride | Tramadol Hydrochloride | Rising Pharma Holdings, Inc. | ANDA | Current |
| 57237-238 | Tramadol Hydrochloride | Tramadol Hydrochloride | Citron Pharma LLC | ANDA | Current |
| 59651-441 | Tramadol Hydrochloride | Tramadol Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-441 | Tramadol Hydrochloride | Tramadol Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-441 | Tramadol Hydrochloride | Tramadol Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-441 | Tramadol Hydrochloride | Tramadol Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-441 | Tramadol Hydrochloride | Tramadol Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-667 | Tramadol Hydrochloride | Tramadol Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-667 | Tramadol Hydrochloride | Tramadol Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-667 | Tramadol Hydrochloride | Tramadol Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-667 | Tramadol Hydrochloride | Tramadol Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 70518-3586 | Tramadol Hydrochloride | Tramadol Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76335 | ORIG | 2023-11-03 |