Application 208269
- Type
- ANDA
- Sponsor
- ALVOGEN PINE BROOK
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 002 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 003 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 40MG | No | No |
| 004 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 005 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 80MG | No | No |
| 006 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 007 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 120MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 47781-392 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-392 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-392 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-393 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-393 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-393 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-394 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-394 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-394 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-395 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-395 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-395 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-396 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-396 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-396 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-397 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-397 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-397 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-398 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-398 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-398 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76469 | ORIG | 2023-11-07 |
| 67033 | ORIG | 2021-04-13 |