Orange Book product · Generic (ANDA)
GUANFACINE HYDROCHLORIDE
GUANFACINE HYDROCHLORIDE
At a glance
Jun 02, 2015
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 02, 2015
11 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
GUANFACINE HYDROCHLORIDE
Strength
EQ 1MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 202578
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GUANFACINE HYDROCHLORIDE
- 2009INTUNIVBrand (NDA)
NDA 022037 · TAKEDA PHARMS USA
- 1986TENEXBrand (NDA)
NDA 019032 · PROMIUS PHARMA
- 2026GUANFACINE HYDROCHLORIDEGeneric (ANDA)
ANDA 220675 · ASCENT PHARMS INC
- 2025GUANFACINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219689 · RUBICON RESEARCH
- 2024GUANFACINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219033 · UNICHEM
- 2024GUANFACINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217638 · FOSUN WANBANG
- 2024GUANFACINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218326 · XIROMED
- 2023GUANFACINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216762 · RUBICON RESEARCH
- 2023GUANFACINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216828 · I 3 PHARMS
- 2023GUANFACINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217269 · ALEMBIC
- 2023GUANFACINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217293 · AJANTA PHARMA LTD
- 2022GUANFACINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216399 · AIPING PHARM INC
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.

