Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071995
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 09/12/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/21/2015 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/21/2015 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/24/2009 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/24/2009 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/12/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/10/2001 | SUPPL-7 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/08/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/27/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PRAZOSIN HYDROCHLORIDE
CAPSULE;ORAL; EQ 2MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MINIPRESS | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 017442 | PFIZER |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217268 | ALEMBIC |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213406 | APPCO |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213052 | AUROBINDO PHARMA LTD |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214608 | GRANULES |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214083 | LANNETT CO INC |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215697 | MANKIND PHARMA |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 072575 | MYLAN |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210971 | NOVITIUM PHARMA |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 071745 | TEVA PHARMS |
| PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 071995 | TEVA PHARMS |