Application 078992
- Type
- ANDA
- Sponsor
- INTELLIPHARMACEUTICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE; ORAL | 5MG | No | No |
| 002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE; ORAL | 10MG | No | No |
| 003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 15MG | No | No |
| 004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE; ORAL | 20MG | No | No |
| 006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE; ORAL | 40MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 49884-428 | Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | Par Pharmaceuticals, Inc. | ANDA | Current |
| 49884-428 | Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | Par Pharmaceuticals, Inc. | ANDA | Current |
| 49884-428 | Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | Par Pharmaceuticals, Inc. | ANDA | Current |
| 49884-430 | Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | Par Pharmaceuticals, Inc. | ANDA | Current |
| 49884-430 | Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | Par Pharmaceuticals, Inc. | ANDA | Current |
| 49884-430 | Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | Par Pharmaceuticals, Inc. | ANDA | Current |
| 63629-2172 | Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2172 | Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2175 | Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2175 | Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9211 | ORIG | 2013-12-05 |