Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | AB | No | No |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | AB | No | No |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | AB | No | No |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
10/18/2000 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75536ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75536ta.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/21/2017 | SUPPL-19 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
09/29/2017 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
04/26/2013 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
06/15/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
12/15/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
03/26/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
07/14/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
06/17/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/26/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/25/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
DOXAZOSIN MESYLATE
TABLET;ORAL; EQ 1MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDURA | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019668 | VIATRIS |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 202824 | ACCORD HLTHCARE |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 075580 | APOTEX |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 075509 | AUROBINDO PHARMA USA |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 205210 | HERITAGE PHARMA |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 212727 | RISING |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 075536 | TEVA |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 212329 | UNICHEM |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 209013 | UPSHER SMITH LABS |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 208719 | ZYDUS PHARMS |
TABLET;ORAL; EQ 2MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDURA | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019668 | VIATRIS |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 202824 | ACCORD HLTHCARE |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 075580 | APOTEX |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 075509 | AUROBINDO PHARMA USA |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 205210 | HERITAGE PHARMA |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 212727 | RISING |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 075536 | TEVA |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 212329 | UNICHEM |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 209013 | UPSHER SMITH LABS |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 208719 | ZYDUS PHARMS |
TABLET;ORAL; EQ 4MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDURA | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019668 | VIATRIS |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 202824 | ACCORD HLTHCARE |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 075580 | APOTEX |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 075509 | AUROBINDO PHARMA USA |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 205210 | HERITAGE PHARMA |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 212727 | RISING |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 075536 | TEVA |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 212329 | UNICHEM |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 209013 | UPSHER SMITH LABS |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 208719 | ZYDUS PHARMS |
TABLET;ORAL; EQ 8MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARDURA | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019668 | VIATRIS |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 202824 | ACCORD HLTHCARE |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 075580 | APOTEX |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 075509 | AUROBINDO PHARMA USA |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 205210 | HERITAGE PHARMA |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 212727 | RISING |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 075536 | TEVA |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 212329 | UNICHEM |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 209013 | UPSHER SMITH LABS |
DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 208719 | ZYDUS PHARMS |