Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021688
Company: AMGEN
Company: AMGEN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SENSIPAR | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
SENSIPAR | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
SENSIPAR | CINACALCET HYDROCHLORIDE | EQ 90MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/08/2004 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21688_sensipar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21688ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-688_Sensipar.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/05/2019 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021688Orig1s027ltr.pdf | |
03/29/2019 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021688Orig1s025, s026ltr.pdf | |
03/29/2019 | SUPPL-25 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021688Orig1s025, s026ltr.pdf | |
05/15/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021688s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021688Orig1s024ltr.pdf | |
05/23/2017 | SUPPL-23 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021688s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021688Orig1s023ltr.pdf | |
11/21/2014 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021688Orig1s020,s021,s022ltr.pdf | |
11/21/2014 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021688Orig1s020,s021,s022ltr.pdf | |
11/21/2014 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021688Orig1s020,s021,s022ltr.pdf | |
08/01/2011 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021688s017ltr.pdf | |
02/25/2011 | SUPPL-15 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021688s015ltr.pdf | |
11/12/2009 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021688s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021688s013ltr.pdf | |
12/19/2008 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s011ltr.pdf | |
05/02/2008 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s009ltr.pdf |
02/28/2008 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s008ltr.pdf | |
10/04/2007 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021688s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021688s006ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/05/2019 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s027lbl.pdf | |
03/29/2019 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s025s026lbl.pdf | |
03/29/2019 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s025s026lbl.pdf | |
05/23/2017 | SUPPL-23 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021688s023lbl.pdf | |
05/15/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021688s024lbl.pdf | |
11/21/2014 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf | |
11/21/2014 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf | |
11/21/2014 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf | |
08/01/2011 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s017lbl.pdf | |
02/25/2011 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s015lbl.pdf | |
11/12/2009 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021688s013lbl.pdf | |
12/19/2008 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s011lbl.pdf | |
02/28/2008 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s008lbl.pdf | |
10/04/2007 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021688s006lbl.pdf | |
03/08/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21688_sensipar_lbl.pdf |
SENSIPAR
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 | 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 | 213325 | CHARTWELL RX |
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 | 210207 | SLATE RUN PHARMA |
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 | 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 | 213325 | CHARTWELL RX |
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 | 210207 | SLATE RUN PHARMA |
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 | 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 | 213325 | CHARTWELL RX |
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 | 210207 | SLATE RUN PHARMA |
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 |