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
CLOPIDOGREL BISULFATE از شرکت TEVA
Abbreviated New Drug Application (ANDA): 076999
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG 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 |
|---|---|---|---|---|---|---|---|
| 05/17/2012 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076999Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2020 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/24/2020 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/24/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/24/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/24/2020 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/28/2015 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
CLOPIDOGREL BISULFATE
TABLET;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 202925 | ACCORD HLTHCARE |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 078004 | ACME LABS |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 204359 | ADAPTIS |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 203751 | AMNEAL PHARMS |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 076274 | APOTEX INC |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 090540 | AUROBINDO PHARMA LTD |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 076273 | DR REDDYS LABS INC |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 202928 | MACLEODS PHARMS LTD |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 213351 | POLYGEN PHARMS |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 206376 | PRINSTON INC |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 204165 | SCIEGEN PHARMS INC |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 090494 | SUN PHARM |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 076999 | TEVA |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | No | AB | 090844 | TORRENT PHARMS LTD |
| PLAVIX | CLOPIDOGREL BISULFATE | EQ 75MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020839 | SANOFI AVENTIS US |
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