Application 078783
- Type
- ANDA
- Sponsor
- PAR PHARM INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-699 | TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | Rebel Distributors Corp. | ANDA | Current |
| 21695-700 | TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | Rebel Distributors Corp. | ANDA | Current |
| 35356-546 | TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-547 | TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49884-822 | TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 50436-0823 | TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | Unit Dose Services | ANDA | Current |
| 61919-895 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-895 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 68258-2003 | TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |