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 L PERRIGO CO
Abbreviated New Drug Application (ANDA): 075285
Company: L PERRIGO CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter |
None |
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 |
|---|---|---|---|---|---|---|---|
| 10/29/1998 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75285ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/21/2020 | SUPPL-44 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/27/2009 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 01/22/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/05/2001 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/11/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/10/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/13/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/25/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
CIMETIDINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 200MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter | No | 074948 | APOTEX |
| CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter | No | 075345 | IVAX SUB TEVA PHARMS |
| CIMETIDINE | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter | No | 075285 | L PERRIGO CO |
| TAGAMET HB | CIMETIDINE | 200MG | TABLET;ORAL | Over-the-counter | Yes | 020238 | MEDTECH PRODUCTS |
نظرات کاربران