Application 216463
- Type
- ANDA
- Sponsor
- ANNORA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 150MG | No | No |
| 002 | MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 200MG | No | No |
| 003 | MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | CAPSULE;ORAL | 250MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-036 | Mexiletine hydrochloride | Mexiletine hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-037 | Mexiletine hydrochloride | Mexiletine hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-038 | Mexiletine hydrochloride | Mexiletine hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |