Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | TABLET;ORAL | EQ 1MG BASE | 0 | HYTRIN | TERAZOSIN HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 2MG BASE | 0 | HYTRIN | TERAZOSIN HYDROCHLORIDE |
| 003 | TABLET;ORAL | EQ 5MG BASE | 0 | HYTRIN | TERAZOSIN HYDROCHLORIDE |
| 004 | TABLET;ORAL | EQ 10MG BASE | 0 | HYTRIN | TERAZOSIN HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1987-08-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1990-08-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-08-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1993-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1993-09-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1994-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1994-09-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-10-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-07-11 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1996-09-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-08-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1998-04-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1998-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2002-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2002-10-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-11-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-12-24 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2006-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2009-07-10 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
CDER Filings
ABBOTT
cder:Array
(
[0] => Array
(
[ApplNo] => 19057
[companyName] => ABBOTT
[docInserts] => ["",""]
[products] => [{"drugName":"HYTRIN","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYTRIN","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYTRIN","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYTRIN","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"07\/10\/2009","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019057s022lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2006","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"HYTRIN","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 1MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYTRIN","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYTRIN","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYTRIN","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2009-07-10
)
)