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 IVAX SUB TEVA PHARMS
Abbreviated New Drug Application (ANDA): 075345
Company: IVAX SUB TEVA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 06/16/1999 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75345ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/26/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/01/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/15/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
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 |
منبع : www.accessdata.fda.gov
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