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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204377
Company: WATSON LABS TEVA

Products on ANDA 204377

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204377

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/2018	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 204377

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

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