Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078962
Company: KVK TECH
Company: KVK TECH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETAXOLOL HYDROCHLORIDE | BETAXOLOL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| BETAXOLOL HYDROCHLORIDE | BETAXOLOL HYDROCHLORIDE | 20MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 06/27/2008 | 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 |
|---|---|---|---|---|---|
| 12/19/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
BETAXOLOL HYDROCHLORIDE
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAXOLOL HYDROCHLORIDE | BETAXOLOL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 075541 | EPIC PHARMA |
| BETAXOLOL HYDROCHLORIDE | BETAXOLOL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078962 | KVK TECH |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAXOLOL HYDROCHLORIDE | BETAXOLOL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 075541 | EPIC PHARMA |
| BETAXOLOL HYDROCHLORIDE | BETAXOLOL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 078962 | KVK TECH |