Orange Book product · Brand (NDA)
NORFLEX
ORPHENADRINE CITRATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ORPHENADRINE CITRATE
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 012157
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —NORFLEXBrand (NDA)
NDA 013055 · PAI HOLDINGS PHARM
- 2012ORPHENADRINE CITRATEGeneric (ANDA)
ANDA 091158 · UNICHEM
- 2011ORPHENADRINE CITRATEGeneric (ANDA)
ANDA 090585 · SAGENT PHARMS
- 2006ORPHENADRINE CITRATEGeneric (ANDA)
ANDA 040484 · RISING
- 2003ORPHENADRINE CITRATEGeneric (ANDA)
ANDA 040463 · HIKMA
- 2000ORPHENADRINE CITRATEGeneric (ANDA)
ANDA 040368 · STEVENS J
- 2000ORPHENADRINE CITRATEGeneric (ANDA)
ANDA 040327 · SANDOZ
- 1999ORPHENADRINE CITRATEGeneric (ANDA)
ANDA 040249 · RISING
- 1998ORPHENADRINE CITRATEGeneric (ANDA)
ANDA 040284 · LUPIN
- 1983ORPHENADRINE CITRATEGeneric (ANDA)
ANDA 088067 · ASCOT
- 1982ORPHENADRINE CITRATEGeneric (ANDA)
ANDA 084779 · WATSON LABS
- —ORPHENADRINE CITRATEGeneric (ANDA)
ANDA 087062 · WATSON LABS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
