Orange Book product · Brand (NDA)
DURACLON
CLONIDINE HYDROCHLORIDE
At a glance
Apr 27, 1999
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 27, 1999
27 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
CLONIDINE HYDROCHLORIDE
Strength
5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020615
Product number
002
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.
- 2025JAVADINBrand (NDA)
NDA 220256 · AZURITY
- 2024ONYDA XRBrand (NDA)
NDA 217645 · TRIS PHARMA INC
- 2009JENLOGABrand (NDA)
NDA 022331 · CONCORDIA PHARMS INC
- —CATAPRESBrand (NDA)
NDA 017407 · BOEHRINGER INGELHEIM
- 2026CLONIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 070923 · TP ANDA HOLDINGS
- 2019CLONIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 209675 · NOVAST LABS
- 2018CLONIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211433 · SOMERSET THERAPS LLC
- 2018CLONIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210680 · RUBICON RESEARCH
- 2018CLONIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210338 · JUBILANT GENERICS
- 2017CLONIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 209686 · AJANTA PHARMA LTD
- 2017CLONIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210052 · AMNEAL PHARMS NY
- 2017CLONIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 209757 · XIAMEN LP PHARM CO
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.
