Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074823
Company: APNAR PHARMA LP
Company: APNAR PHARMA LP
| 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 |
|---|---|---|---|---|---|---|---|
| 03/30/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74823ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/09/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/01/2002 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/05/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/07/1999 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/18/1999 | SUPPL-1 | Manufacturing (CMC) |
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 |