Application 078331
- Type
- ANDA
- Sponsor
- AM REGENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 0.3MG BASE/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0517-0725 | Buprenorphine Hydrochloride | Buprenorphine Hydrochloride | American Regent, Inc. | ANDA | Current |
| 0517-0725 | Buprenorphine Hydrochloride | Buprenorphine Hydrochloride | American Regent, Inc. | ANDA | Current |
| 0517-0725 | Buprenorphine Hydrochloride | Buprenorphine Hydrochloride | American Regent, Inc. | ANDA | Current |