Orange Book product · Brand (NDA)
HYTRIN
TERAZOSIN HYDROCHLORIDE
At a glance
Dec 14, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 14, 1994
32 yr ago
Today
Pharmaceutical detail
Active ingredient
TERAZOSIN HYDROCHLORIDE
Strength
EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 020347
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.
- 2024TEZRULYBrand (NDA)
NDA 218139 · NOVITIUM PHARMA
- 1987HYTRINBrand (NDA)
NDA 019057 · ABBOTT
- 2025TERAZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 219482 · AJANTA PHARMA LTD
- 2004TERAZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 075317 · JUBILANT CADISTA
- 2002TERAZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 076021 · RANBAXY LABS LTD
- 2001TERAZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 075498 · HIKMA
- 2001TERAZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 075614 · HERITAGE PHARMA AVET
- 2000TERAZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 075384 · PHARMOBEDIENT
- 2000TERAZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 075667 · BIONPHARMA
- 2000TERAZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 074446 · TEVA
- 2000TERAZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 074657 · CHARTWELL RX
- 2000TERAZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 074530 · IVAX SUB TEVA 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.
