FDA Approval for PRAZOSIN HYDROCHLORIDE issued to LANNETT CO INC
$LCI
Biotechnology: Pharmaceutical Preparations
Health Care
Abbreviated New Drug Application (ANDA): 214083
Company: LANNETT CO INC
Company: LANNETT CO INC
| 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 |
|---|---|---|---|---|---|---|---|
| 01/03/2024 | 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 | 214083 | LANNETT CO INC |
| 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 | 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 | 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 |
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 | 214083 | LANNETT CO INC |
| 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 | 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 |