Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075750
Company: PLIVA
Company: PLIVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 1MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 2MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 4MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| DOXAZOSIN MESYLATE | DOXAZOSIN MESYLATE | EQ 8MG 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 |
|---|---|---|---|---|---|---|---|
| 06/08/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75750ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/02/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |