Application 210162
- Type
- ANDA
- Sponsor
- MYLAN TECHNOLOGIES
Application Products#
Product, Drug, Ingredient table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76472 | ORIG | 2023-11-07 |