Application 207490
- Type
- ANDA
- Sponsor
- ALVOGEN PINE BROOK
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 | 10MCG/HR | No | No |
| 003 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 15MCG/HR | No | No |
| 004 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 20MCG/HR | No | No |
| 005 | BUPRENORPHINE | BUPRENORPHINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 7.5MCG/HR | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 47781-406 | buprenorphine transdermal system | buprenorphine | Alvogen Inc. | ANDA | Current |
| 47781-407 | buprenorphine transdermal system | buprenorphine | Alvogen Inc. | ANDA | Current |
| 47781-408 | buprenorphine transdermal system | buprenorphine | Alvogen Inc. | ANDA | Current |
| 47781-419 | buprenorphine transdermal system | buprenorphine | Alvogen Inc. | ANDA | Current |
| 58064-408 | buprenorphine transdermal system | buprenorphine | LTS Therapy Systems, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76485 | ORIG | 2023-11-07 |