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
CINACALCET HYDROCHLORIDE از شرکت SUN PHARM
Abbreviated New Drug Application (ANDA): 207008
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription |
AB |
No | No |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription |
AB |
No | No |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG 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 |
|---|---|---|---|---|---|---|---|
| 10/11/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/04/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/04/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2020 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
CINACALCET HYDROCHLORIDE
TABLET;ORAL; EQ 30MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 211892 | ACCORD HLTHCARE |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 213325 | ACME LABS |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 210570 | ALKEM LABS LTD |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 206125 | AUROBINDO PHARMA LTD |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 208915 | CIPLA |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 208368 | DR REDDYS |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 209403 | HETERO LABS LTD V |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 203422 | MYLAN |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 210207 | PIRAMAL HLTHCARE UK |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 209226 | STRIDES PHARMA |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 207008 | SUN PHARM |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 204377 | WATSON LABS TEVA |
| SENSIPAR | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021688 | AMGEN |
TABLET;ORAL; EQ 60MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 211892 | ACCORD HLTHCARE |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 213325 | ACME LABS |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 210570 | ALKEM LABS LTD |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 206125 | AUROBINDO PHARMA LTD |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 208915 | CIPLA |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 208368 | DR REDDYS |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 209403 | HETERO LABS LTD V |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 203422 | MYLAN |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 210207 | PIRAMAL HLTHCARE UK |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 209226 | STRIDES PHARMA |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 207008 | SUN PHARM |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 204377 | WATSON LABS TEVA |
| SENSIPAR | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021688 | AMGEN |
TABLET;ORAL; EQ 90MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | No | AB | 211892 | ACCORD HLTHCARE |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | No | AB | 213325 | ACME LABS |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | No | AB | 210570 | ALKEM LABS LTD |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | No | AB | 206125 | AUROBINDO PHARMA LTD |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | No | AB | 208915 | CIPLA |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | No | AB | 208368 | DR REDDYS |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | No | AB | 209403 | HETERO LABS LTD V |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | No | AB | 203422 | MYLAN |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | No | AB | 210207 | PIRAMAL HLTHCARE UK |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | No | AB | 209226 | STRIDES PHARMA |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | No | AB | 207008 | SUN PHARM |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | No | AB | 204377 | WATSON LABS TEVA |
| SENSIPAR | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021688 | AMGEN |
منبع : www.accessdata.fda.gov
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