Application 207152
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 325MG;37.5MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-3248 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | A-S Medication Solutions | ANDA | Current |
| 60760-922 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 65862-922 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-922 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-922 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-922 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | Aurobindo Pharma Limited | ANDA | Current |
| 65862-922 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | Aurobindo Pharma Limited | ANDA | Current |
| 68071-2351 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2351 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71205-625 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 71205-625 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | Proficient Rx LP | ANDA | Current |
| 71335-1742 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 71335-1742 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | Bryant Ranch Prepack | ANDA | Current |
| 72189-382 | Tramadol Hydrochloride and Acetaminophen | Tramadol Hydrochloride and Acetaminophen | Direct_Rx | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76055 | ORIG | 2023-11-02 |