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
ALOSETRON HYDROCHLORIDE از شرکت HIKMA
Abbreviated New Drug Application (ANDA): 200652
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription |
AB |
No | No |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 05/04/2015 | ORIG-1 | Approval |
Not Applicable |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200652Orig1s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/06/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2016 | SUPPL-4 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200652Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/200652Orig1s004.pdf |
|
| 03/24/2016 | SUPPL-3 | REMS-Modified |
Label is not available on this site. |
||
| 01/07/2016 | SUPPL-2 | REMS-Modified |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/04/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200652Orig1s000lbl.pdf |
ALOSETRON HYDROCHLORIDE
TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 206647 | AMNEAL PHARMS |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 200652 | HIKMA |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 213614 | MANKIND PHARMA |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 206113 | PAR PHARM INC |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | No | AB | 209180 | RISING |
| LOTRONEX | ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021107 | SEBELA IRELAND LTD |
TABLET;ORAL; EQ 1MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 206647 | AMNEAL PHARMS |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 200652 | HIKMA |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 213614 | MANKIND PHARMA |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 206113 | PAR PHARM INC |
| ALOSETRON HYDROCHLORIDE | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 209180 | RISING |
| LOTRONEX | ALOSETRON HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021107 | SEBELA IRELAND LTD |
نظرات کاربران