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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219796
Company: HUMANWELL PURACAP

Products on ANDA 219796

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE;ORAL	Prescription	AB	No	No
CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219796

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219796Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 219796

CALCITRIOL

CAPSULE;ORAL; 0.25MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE;ORAL	Prescription	No	AB	203289	AMNEAL PHARMS
CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE;ORAL	Prescription	No	AB	091174	BIONPHARMA
CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE;ORAL	Prescription	No	AB	076917	HIKMA
CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE;ORAL	Prescription	No	AB	219796	HUMANWELL PURACAP
CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE;ORAL	Prescription	No	AB	091356	ONESOURCE SPECIALTY
CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE;ORAL	Prescription	No	AB	075765	TEVA
ROCALTROL	CALCITRIOL	0.25MCG	CAPSULE;ORAL	Prescription	Yes	AB	018044	ESJAY PHARMA

CAPSULE;ORAL; 0.5MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE;ORAL	Prescription	No	AB	203289	AMNEAL PHARMS
CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE;ORAL	Prescription	No	AB	091174	BIONPHARMA
CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE;ORAL	Prescription	No	AB	219796	HUMANWELL PURACAP
CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE;ORAL	Prescription	No	AB	091356	ONESOURCE SPECIALTY
CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE;ORAL	Prescription	No	AB	075765	TEVA
ROCALTROL	CALCITRIOL	0.5MCG	CAPSULE;ORAL	Prescription	Yes	AB	018044	ESJAY PHARMA

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