FdaApplication
NDA 202880
Identifiers
- fda_app_no: NDA202880
Properties
| Property | Value |
|---|---|
| applicant_name | RECRO GAINESVILLE LLC |
| application_type | NDA |
| approval_date | 2013-10-25 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZOHYDRO ER | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL |
| ZOHYDRO ER | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL |
| ZOHYDRO ER | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL |
| ZOHYDRO ER | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL |
| ZOHYDRO ER | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL |
| ZOHYDRO ER | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL |
6 products