Drugs@FDA: FDA-Approved Drugs
Company: ABBOTT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Discontinued | None | No | No |
HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Discontinued | None | No | No |
HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
HYTRIN | TERAZOSIN HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
08/07/1987 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
07/10/2009 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019057s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019057s022ltr.pdf | |
02/06/2006 | SUPPL-21 | 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 | |
12/24/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/15/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/04/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/23/2002 | SUPPL-15 | 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/2002/19-057-S015.pdf |
08/06/1998 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/16/1998 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/08/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/18/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
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07/11/1995 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/06/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/14/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
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06/17/1994 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/29/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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08/20/1993 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/09/1991 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/10/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
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09/20/1988 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/01/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/10/2009 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019057s022lbl.pdf | |
02/06/2006 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19057Orig1s021, 20347Orig1s009 lbl.pdf |