Application 206734
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| 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 | 20MG | No | No |
| 005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 25MG | No | No |
| 006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 35MG | No | No |
| 008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-562 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-563 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-564 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-565 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-566 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-567 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-568 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-569 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Northstar Rx LLC | ANDA | Current |
| 57664-621 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-622 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-623 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-624 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-625 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-626 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-628 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-629 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |