Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | CAPSULE;ORAL | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | HYTRIN | TERAZOSIN HYDROCHLORIDE |
| 002 | CAPSULE;ORAL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | HYTRIN | TERAZOSIN HYDROCHLORIDE |
| 003 | CAPSULE;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | HYTRIN | TERAZOSIN HYDROCHLORIDE |
| 004 | CAPSULE;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | HYTRIN | TERAZOSIN HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1994-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1996-09-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-08-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1998-04-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2002-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2006-02-06 | STANDARD |
Submissions Property Types
| ORIG | 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 | 9 | Null | 0 |
CDER Filings
ABBOTT
cder:Array
(
[0] => Array
(
[ApplNo] => 20347
[companyName] => ABBOTT
[docInserts] => ["",""]
[products] => [{"drugName":"HYTRIN","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"HYTRIN","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"HYTRIN","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"HYTRIN","activeIngredients":"TERAZOSIN HYDROCHLORIDE","strength":"EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"02\/06\/2006","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"HYTRIN","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"HYTRIN","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"HYTRIN","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"HYTRIN","submission":"TERAZOSIN HYDROCHLORIDE","actionType":"EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2006-02-06
)
)