Drugs@FDA: FDA-Approved Drugs
Company: AUROBINDO PHARMA USA
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 |
---|---|---|---|---|---|---|---|
10/19/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75509ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/21/2017 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
09/22/2014 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
02/24/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
07/08/2011 | SUPPL-15 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/01/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
01/21/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
03/25/2002 | 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 PHARMA |
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 PHARMA |
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 PHARMA |
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 PHARMA |
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 |