Application 083185
- Type
- ANDA
- Sponsor
- NEXGEN PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROPOXYPHENE HYDROCHLORIDE | PROPOXYPHENE HYDROCHLORIDE | CAPSULE;ORAL | 65MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A083185-001 | PROPOXYPHENE HYDROCHLORIDE | PROPOXYPHENE HYDROCHLORIDE | 65MG | CAPSULE / ORAL | Approved before 1982 |