Application 216243
- Type
- ANDA
- Sponsor
- CENTAUR PHARMS PVT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No |
| 005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 150MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 64330-630 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Centaur Pharmaceuticals Private Limited | ANDA | Current |
| 64330-631 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Centaur Pharmaceuticals Private Limited | ANDA | Current |
| 64330-632 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Centaur Pharmaceuticals Private Limited | ANDA | Current |
| 64330-633 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Centaur Pharmaceuticals Private Limited | ANDA | Current |
| 64330-634 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Centaur Pharmaceuticals Private Limited | ANDA | Current |
| 64330-635 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Centaur Pharmaceuticals Private Limited | ANDA | Current |