Application 211594
- Type
- ANDA
- Sponsor
- ALVOGEN MALTA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | FILM;BUCCAL | EQ 0.075MG BASE | No | No |
| 002 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | FILM;BUCCAL | EQ 0.15MG BASE | No | No |
| 003 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | FILM;BUCCAL | EQ 0.3MG BASE | No | No |
| 004 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | FILM;BUCCAL | EQ 0.45MG BASE | No | No |
| 005 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | FILM;BUCCAL | EQ 0.6MG BASE | No | No |
| 006 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | FILM;BUCCAL | EQ 0.75MG BASE | No | No |
| 007 | BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | FILM;BUCCAL | EQ 0.9MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47781-400 | buprenorphine buccal film | buprenorphine buccal | Alvogen, Inc. | ANDA | Current |
| 47781-425 | buprenorphine buccal film | buprenorphine buccal | Alvogen, Inc. | ANDA | Current |
| 47781-471 | buprenorphine buccal film | buprenorphine buccal | Alvogen, Inc. | ANDA | Current |
| 47781-472 | buprenorphine buccal film | buprenorphine buccal | Alvogen, Inc. | ANDA | Current |
| 47781-473 | buprenorphine buccal film | buprenorphine buccal | Alvogen, Inc. | ANDA | Current |
| 47781-474 | buprenorphine buccal film | buprenorphine buccal | Alvogen, Inc. | ANDA | Current |
| 47781-475 | buprenorphine buccal film | buprenorphine buccal | Alvogen, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66705 | ORIG | 2021-03-10 |