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 POLYGEN PHARMS
Abbreviated New Drug Application (ANDA): 213351
Company: POLYGEN PHARMS
| 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 |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 300MG 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 |
|---|---|---|---|---|---|---|---|
| 07/17/2020 | ORIG-1 | Approval |
STANDARD |
|
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 |
TABLET;ORAL; EQ 300MG 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 300MG BASE | TABLET;ORAL | Prescription | No | AB | 202925 | ACCORD HLTHCARE |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 076274 | APOTEX INC |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 091023 | DR REDDYS LABS LTD |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 213351 | POLYGEN PHARMS |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 206376 | PRINSTON INC |
| CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 204165 | SCIEGEN PHARMS INC |
| PLAVIX | CLOPIDOGREL BISULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020839 | SANOFI AVENTIS US |
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