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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090829
Company: TEVA PHARMS USA

Products on ANDA 090829

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PARICALCITOL	PARICALCITOL	1MCG	CAPSULE;ORAL	Prescription	AB	No	No
PARICALCITOL	PARICALCITOL	2MCG	CAPSULE;ORAL	Prescription	AB	No	No
PARICALCITOL	PARICALCITOL	4MCG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090829

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2013	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090829s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090829

PARICALCITOL

CAPSULE;ORAL; 1MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PARICALCITOL	PARICALCITOL	1MCG	CAPSULE;ORAL	Prescription	No	AB	204327	AMNEAL PHARMS
PARICALCITOL	PARICALCITOL	1MCG	CAPSULE;ORAL	Prescription	No	AB	207672	AUROBINDO PHARMA LTD
PARICALCITOL	PARICALCITOL	1MCG	CAPSULE;ORAL	Prescription	No	AB	202539	BIONPHARMA
PARICALCITOL	PARICALCITOL	1MCG	CAPSULE;ORAL	Prescription	No	AB	091412	DR REDDYS
PARICALCITOL	PARICALCITOL	1MCG	CAPSULE;ORAL	Prescription	No	AB	204948	MARKSANS PHARMA
PARICALCITOL	PARICALCITOL	1MCG	CAPSULE;ORAL	Prescription	No	AB	202124	RISING
PARICALCITOL	PARICALCITOL	1MCG	CAPSULE;ORAL	Prescription	No	AB	090829	TEVA PHARMS USA
ZEMPLAR	PARICALCITOL	1MCG	CAPSULE;ORAL	Prescription	Yes	AB	021606	ABBVIE

CAPSULE;ORAL; 2MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PARICALCITOL	PARICALCITOL	2MCG	CAPSULE;ORAL	Prescription	No	AB	204327	AMNEAL PHARMS
PARICALCITOL	PARICALCITOL	2MCG	CAPSULE;ORAL	Prescription	No	AB	207672	AUROBINDO PHARMA LTD
PARICALCITOL	PARICALCITOL	2MCG	CAPSULE;ORAL	Prescription	No	AB	202539	BIONPHARMA
PARICALCITOL	PARICALCITOL	2MCG	CAPSULE;ORAL	Prescription	No	AB	091412	DR REDDYS
PARICALCITOL	PARICALCITOL	2MCG	CAPSULE;ORAL	Prescription	No	AB	204948	MARKSANS PHARMA
PARICALCITOL	PARICALCITOL	2MCG	CAPSULE;ORAL	Prescription	No	AB	202124	RISING
PARICALCITOL	PARICALCITOL	2MCG	CAPSULE;ORAL	Prescription	No	AB	090829	TEVA PHARMS USA
ZEMPLAR	PARICALCITOL	2MCG	CAPSULE;ORAL	Prescription	Yes	AB	021606	ABBVIE

CAPSULE;ORAL; 4MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PARICALCITOL	PARICALCITOL	4MCG	CAPSULE;ORAL	Prescription	No	AB	204327	AMNEAL PHARMS
PARICALCITOL	PARICALCITOL	4MCG	CAPSULE;ORAL	Prescription	No	AB	207672	AUROBINDO PHARMA LTD
PARICALCITOL	PARICALCITOL	4MCG	CAPSULE;ORAL	Prescription	No	AB	202539	BIONPHARMA
PARICALCITOL	PARICALCITOL	4MCG	CAPSULE;ORAL	Prescription	No	AB	091412	DR REDDYS
PARICALCITOL	PARICALCITOL	4MCG	CAPSULE;ORAL	Prescription	No	AB	204948	MARKSANS PHARMA
PARICALCITOL	PARICALCITOL	4MCG	CAPSULE;ORAL	Prescription	No	AB	202124	RISING
PARICALCITOL	PARICALCITOL	4MCG	CAPSULE;ORAL	Prescription	No	AB	090829	TEVA PHARMS USA

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