Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205210
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
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 |
---|---|---|---|---|---|---|---|
02/13/2018 | ORIG-1 | Approval | 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 |
---|---|---|---|---|---|
05/09/2024 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels |
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 |