Application 090404
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
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 |
|---|
| 0904-6365 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Major Pharmaceuticals | ANDA | Current |
| 0904-6365 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Major Pharmaceuticals | ANDA | Current |
| 51655-182 | Tramadol HCl | Tramadol HCl | Northwind Pharmaceuticals | ANDA | Current |
| 52959-688 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | H.J. Harkins Company Inc. | ANDA | Current |
| 58118-0319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60760-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-597 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DirectRX | ANDA | Current |
| 61919-597 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DirectRX | ANDA | Current |
| 65841-754 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Cadila Healthcare Limited | ANDA | Current |
| 65841-754 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Cadila Healthcare Limited | ANDA | Current |
| 65841-754 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Cadila Healthcare Limited | ANDA | Current |
| 65841-754 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Zydus Lifesciences Limited | ANDA | Current |
| 65841-754 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Cadila Healthcare Limited | ANDA | Current |
| 67046-731 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1649 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1649 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 68071-3280 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3321 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4070 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,In | ANDA | Current |
| 68071-4070 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4070 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4165 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4165 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4165 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68382-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68788-6929 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71205-066 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71205-066 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 71335-1003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76214 | ORIG | 2023-11-03 |