Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075667
Company: BIONPHARMA
Company: BIONPHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 10MG 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 |
---|---|---|---|---|---|---|---|
07/28/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75667ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/19/2024 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
TERAZOSIN 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 |
---|---|---|---|---|---|---|---|---|
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074823 | APNAR PHARMA LP |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075667 | BIONPHARMA |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075614 | HERITAGE PHARMA AVET |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 1MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075317 | JUBILANT CADISTA |
CAPSULE;ORAL; EQ 2MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074823 | APNAR PHARMA LP |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075667 | BIONPHARMA |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075614 | HERITAGE PHARMA AVET |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075317 | JUBILANT CADISTA |
CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074823 | APNAR PHARMA LP |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075667 | BIONPHARMA |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075614 | HERITAGE PHARMA AVET |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075317 | JUBILANT CADISTA |
CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074823 | APNAR PHARMA LP |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075667 | BIONPHARMA |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075614 | HERITAGE PHARMA AVET |
TERAZOSIN HYDROCHLORIDE | TERAZOSIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075317 | JUBILANT CADISTA |