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
CIMETIDINE HYDROCHLORIDE از شرکت AKORN
Abbreviated New Drug Application (ANDA): 074664
Company: AKORN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIMETIDINE HYDROCHLORIDE | CIMETIDINE HYDROCHLORIDE | EQ 300MG BASE/5ML | SOLUTION;ORAL | Prescription |
AA |
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 |
|---|---|---|---|---|---|---|---|
| 10/28/1997 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75664ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/13/2019 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
CIMETIDINE HYDROCHLORIDE
SOLUTION;ORAL; EQ 300MG BASE/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIMETIDINE HYDROCHLORIDE | CIMETIDINE HYDROCHLORIDE | EQ 300MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 074664 | AKORN |
| CIMETIDINE HYDROCHLORIDE | CIMETIDINE HYDROCHLORIDE | EQ 300MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 074553 | PHARM ASSOC |
| CIMETIDINE HYDROCHLORIDE | CIMETIDINE HYDROCHLORIDE | EQ 300MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 074757 | WOCKHARDT BIO AG |
نظرات کاربران