Orange Book product · Brand (NDA)
CATAPRES
CLONIDINE HYDROCHLORIDE
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
CLONIDINE HYDROCHLORIDE
Strength
0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 017407
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.
- 2025JAVADINBrand (NDA)
NDA 220256 · AZURITY
- 2024ONYDA XRBrand (NDA)
NDA 217645 · TRIS PHARMA INC
- 2009JENLOGABrand (NDA)
NDA 022331 · CONCORDIA PHARMS INC
- 1996DURACLONBrand (NDA)
NDA 020615 · MYLAN INSTITUTIONAL
- 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.
