Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020347
Company: ABBOTT
Company: ABBOTT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/14/1994 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/06/2006 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19057Orig1s021, 20347Orig1s009 lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019057Orig1s021,020347Orig1s009 ltr.pdf | |
10/04/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/23/2002 | SUPPL-6 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19057s15ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-347-S006.pdf |
08/06/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/16/1998 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/08/1996 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/18/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
03/14/1995 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/06/2006 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19057Orig1s021, 20347Orig1s009 lbl.pdf |