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 از شرکت MYLAN
Abbreviated New Drug Application (ANDA): 074246
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CIMETIDINE | CIMETIDINE | 300MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CIMETIDINE | CIMETIDINE | 400MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CIMETIDINE | CIMETIDINE | 800MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/17/1994 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/07/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/03/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/17/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |
CIMETIDINE
TABLET;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Prescription | No | AB | 074246 | MYLAN |
| CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Prescription | No | AB | 074151 | TEVA |
TABLET;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIMETIDINE | CIMETIDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 074246 | MYLAN |
| CIMETIDINE | CIMETIDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 074151 | TEVA |
TABLET;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIMETIDINE | CIMETIDINE | 400MG | TABLET;ORAL | Prescription | No | AB | 074246 | MYLAN |
| CIMETIDINE | CIMETIDINE | 400MG | TABLET;ORAL | Prescription | No | AB | 074151 | TEVA |
TABLET;ORAL; 800MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIMETIDINE | CIMETIDINE | 800MG | TABLET;ORAL | Prescription | No | AB | 074246 | MYLAN |
| CIMETIDINE | CIMETIDINE | 800MG | TABLET;ORAL | Prescription | No | AB | 074566 | PLIVA |
| CIMETIDINE | CIMETIDINE | 800MG | TABLET;ORAL | Prescription | No | AB | 074463 | TEVA |
منبع : www.accessdata.fda.gov
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