Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203897
Company: RISING

Products on ANDA 203897

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PARICALCITOL	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	No	No
PARICALCITOL	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
PARICALCITOL	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203897

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/02/2017	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2025	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
07/23/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203897

PARICALCITOL

SOLUTION;INTRAVENOUS; 0.005MG/ML (0.005MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PARICALCITOL	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207174	ACCORD HLTHCARE
PARICALCITOL	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	206699	AMNEAL PHARMS CO
PARICALCITOL	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	204910	CAPLIN
PARICALCITOL	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	203897	RISING
PARICALCITOL	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	091108	SANDOZ
ZEMPLAR	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	020819	ABBVIE

SOLUTION;INTRAVENOUS; 0.01MG/2ML (0.005MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PARICALCITOL	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207174	ACCORD HLTHCARE
PARICALCITOL	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	206699	AMNEAL PHARMS CO
PARICALCITOL	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	204910	CAPLIN
PARICALCITOL	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	203897	RISING
PARICALCITOL	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	091108	SANDOZ
ZEMPLAR	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	020819	ABBVIE