Application 212756
- Type
- ANDA
- Sponsor
- AVEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL, SUBLINGUAL | EQ 8MG BASE;EQ 2MG BASE | No | No |
| 002 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL, SUBLINGUAL | EQ 12MG BASE;EQ 3MG BASE | No | No |
| 003 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL, SUBLINGUAL | EQ 2MG BASE;EQ 0.5MG BASE | No | No |
| 004 | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | FILM;BUCCAL, SUBLINGUAL | EQ 4MG BASE;EQ 1MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-7053 | Buprenorphine and Naloxone | buprenorphine and naloxone | Apotex Corp. | ANDA | Current |
| 60505-7053 | Buprenorphine and Naloxone | buprenorphine and naloxone | Apotex Corp. | ANDA | Current |
| 60505-7053 | Buprenorphine and Naloxone | buprenorphine and naloxone | Apotex Corp. | ANDA | Current |
| 60505-7054 | Buprenorphine and Naloxone | buprenorphine and naloxone | Apotex Corp. | ANDA | Current |
| 60505-7054 | Buprenorphine and Naloxone | buprenorphine and naloxone | Apotex Corp. | ANDA | Current |
| 60505-7054 | Buprenorphine and Naloxone | buprenorphine and naloxone | Apotex Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76399 | ORIG | 2023-11-06 |