TAPENTADOL HYDROCHLORIDE | A205057 | HIKMA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Janssen Pharmaceuticals, Inc. et al v. Roxane Laboratories, Inc. 1 patentANDA 205057tapentadol hydrochloride | NVD | 2013-11-15 | Terminated 2014-03-12 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.
Hikma's Tapentadol Hydrochloride NDA 205057 (Supplement 003) changed from prescription status to discontinued, removing active marketing authorization.
Old: RX
New: DISCN
Hikma's Tapentadol Hydrochloride (NDA 205057) transitioned from prescription to discontinued status in the FDA's product records.
Old: RX
New: DISCN
Hikma's tapentadol hydrochloride product (NDA 205057) transitioned from prescription to discontinued status.
Old: RX
New: DISCN
HIKMA's tapentadol hydrochloride NDA 205057 therapeutic equivalence code changed from AB to a different rating.
Old: AB
Hikma's tapentadol hydrochloride (TAPENTADOL HYDROCHLORIDE) therapeutic equivalence code changed from AB, affecting generic substitutability status for this abbreviated new drug application.
Old: AB
Hikma's Tapentadol Hydrochloride (NDA 205057, supplement 002) therapeutic equivalence code changed from AB to a different rating.
Old: AB