Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209226
Company: STRIDES PHARMA
Company: STRIDES PHARMA
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 |
---|---|---|---|---|---|---|---|
04/30/2018 | 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 |
---|---|---|---|---|---|
05/18/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
05/18/2020 | SUPPL-3 | 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 | 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 |