Orange Book product · Brand (NDA)
NORTHERA
DROXIDOPA
At a glance
Feb 18, 2014
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 18, 2014
12 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DROXIDOPA
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 203202
Product number
001
Marketing status
RX
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.
- 2022DROXIDOPAGeneric (ANDA)
ANDA 214217 · CHARTWELL RX
- 2021DROXIDOPAGeneric (ANDA)
ANDA 215265 · ADAPTIS
- 2021DROXIDOPAGeneric (ANDA)
ANDA 211726 · ANNORA
- 2021DROXIDOPAGeneric (ANDA)
ANDA 214543 · SOMERSET THERAPS LLC
- 2021DROXIDOPAGeneric (ANDA)
ANDA 213033 · BIONPHARMA
- 2021DROXIDOPAGeneric (ANDA)
ANDA 213911 · ALKEM LABS LTD
- 2021DROXIDOPAGeneric (ANDA)
ANDA 214387 · AUROBINDO PHARMA LTD
- 2021DROXIDOPAGeneric (ANDA)
ANDA 212835 · HIKMA
- 2021DROXIDOPAGeneric (ANDA)
ANDA 214391 · JUBILANT CADISTA
- 2021DROXIDOPAGeneric (ANDA)
ANDA 211652 · LUPIN PHARMS
- 2021DROXIDOPAGeneric (ANDA)
ANDA 211741 · MSN PHARMS INC
- 2021DROXIDOPAGeneric (ANDA)
ANDA 214017 · SCIEGEN PHARMS
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.

