Application 213999
- Type
- ANDA
- Sponsor
- MANKIND PHARMA
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70756-201 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-202 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-203 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-204 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-205 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Lifestar Pharma LLC | ANDA | Current |
| 70756-206 | Amitriptyline Hydrochloride | Amitriptyline Hydrochloride | Lifestar Pharma LLC | ANDA | Current |