Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214608
Company: GRANULES
Company: GRANULES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG 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 |
---|---|---|---|---|---|---|---|
12/23/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PRAZOSIN HYDROCHLORIDE
CAPSULE;ORAL; EQ 1MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MINIPRESS | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 017442 | PFIZER |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217268 | ALEMBIC |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213406 | APPCO |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213052 | AUROBINDO PHARMA LTD |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214608 | GRANULES |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 071994 | IVAX SUB TEVA PHARMS |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215697 | MANKIND PHARMA |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 216727 | MSN |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 072575 | MYLAN |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210971 | NOVITIUM PHARMA |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 071745 | TEVA PHARMS |
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 | 215697 | MANKIND PHARMA |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 216727 | MSN |
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 |
CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MINIPRESS | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 017442 | PFIZER |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217268 | ALEMBIC |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213406 | APPCO |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213052 | AUROBINDO PHARMA LTD |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214608 | GRANULES |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215697 | MANKIND PHARMA |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 216727 | MSN |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 072575 | MYLAN |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210971 | NOVITIUM PHARMA |
PRAZOSIN HYDROCHLORIDE | PRAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 071745 | TEVA PHARMS |