Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075541
Company: EPIC PHARMA
Company: EPIC PHARMA
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/22/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75441ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/19/2014 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075541Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/075541Orig1s010ltr.pdf | |
11/02/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
11/02/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/19/2014 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075541Orig1s010lbl.pdf | |
12/19/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075541Orig1s010lbl.pdf |
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 |