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
BENZPHETAMINE HYDROCHLORIDE از شرکت ANDA REPOSITORY
Abbreviated New Drug Application (ANDA): 090473
Company: ANDA REPOSITORY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENZPHETAMINE HYDROCHLORIDE | BENZPHETAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription |
None |
No | No |
| BENZPHETAMINE HYDROCHLORIDE | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription |
AA |
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 |
|---|---|---|---|---|---|---|---|
| 09/15/2010 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090473Orig1s000LBL.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/06/2021 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2010 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
BENZPHETAMINE HYDROCHLORIDE
TABLET;ORAL; 50MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENZPHETAMINE HYDROCHLORIDE | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 090473 | ANDA REPOSITORY |
| BENZPHETAMINE HYDROCHLORIDE | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 090346 | EPIC PHARMA LLC |
| BENZPHETAMINE HYDROCHLORIDE | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 090968 | KVK TECH |
نظرات کاربران