Application 204318
- Type
- ANDA
- Sponsor
- AUROLIFE PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | CAPSULE;ORAL | 15MG | No | No |
| 002 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 13107-105 | Phentermine | Phentermine Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-106 | Phentermine | Phentermine Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 50090-3282 | Phentermine | Phentermine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3282 | Phentermine | Phentermine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3282 | Phentermine | Phentermine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3306 | Phentermine | Phentermine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3306 | Phentermine | Phentermine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 68788-7691 | Phentermine | Phentermine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |