Application 206986
- Type
- ANDA
- Sponsor
- ALVOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 002 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 15MG | No | No |
| 003 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 004 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 005 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | No | No |
| 006 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47781-409 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-409 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-409 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-410 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-410 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-410 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-411 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-411 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-411 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-412 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-412 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-412 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-413 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-413 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-413 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-414 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-414 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |
| 47781-414 | Hydrocodone Bitartrate | Hydrocodone Bitartrate | Alvogen Inc. | ANDA | Current |