اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BETAXOLOL HYDROCHLORIDE از شرکت EPIC PHARMA
Abbreviated New Drug Application (ANDA): 075541
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 |
|
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-Package Insert, Labeling-Medication Guide |
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-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075541Orig1s010lbl.pdf | |
| 12/19/2014 | SUPPL-10 |
Labeling-Medication Guide |
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 |
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