Application 210272
- Type
- ANDA
- Sponsor
- AVEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 5MCG/HR | No | No |
| 002 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 7.5MCG/HR | No | No |
| 003 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 10MCG/HR | No | No |
| 004 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 15MCG/HR | No | No |
| 005 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 20MCG/HR | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-7075 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7075 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7075 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7076 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7076 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7076 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7077 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7077 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7077 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7078 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7078 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7078 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7079 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7079 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
| 60505-7079 | Buprenorphene | Buprenorphene | Apotex Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76479 | ORIG | 2023-11-07 |